Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AIDS Malignancy Consortium A Trial of the AIDS Malignancy Consortium (AMC)
Conditions: HIV-Associated Malignant Neoplasm, HIV Infections, Cancer, AIDS Related Lymphoma, AIDS-related Kaposi Sarcoma, AIDS-Related Malignancy, Anal Cancer, HPV-Related Malignancy
Sponsor: AIDS Malignancy Consortium

AMC-115 (Version 4.0) 11AUG2022 
 
 
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AIDS MALIGNANCY CONSORTIUM 
 
AMC PROTOCOL #115: 
Use of a Screening Tool to Describe HIV-Related Cancer Burden 
and Patient Characteristics in the AIDS Malignancy Consortium 
A Trial of the AIDS Malignancy Consortium (AMC) 
 
Sponsored by: 
National Cancer Institute 
Office of HIV and AIDS Malignancy (OHAM) 
 
NCT Registration Number: 
TBD 
 
Protocol Chair: 
Anna E. Coghill, PhD, MPH 
 
Protocol Co-Chair(s): 
Thomas M. Atkinson, PhD 
Elizabeth Chiao, MD, MPH 
Version 4.0, August 11, 2022 
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AMC PROTOCOL SIGNATURE PAGE 
I, ____________________, Principal Investigator at site ________, agree to conduct and follow 
this protocol: AMC Protocol #115 – Use of a Screening Tool to Describe HIV-Related Cancer 
Burden and Patient Characteristics in the AIDS Malignancy Consortium (Version 4.0, 
11AUG2022), as written according to AMC and NCI, and standards of Good Clinical Practice 
(GCP, ICH E6 R2). I understand that no deviations from the protocol eligibility criteria or waivers 
for protocol deviations will be permitted. 
 
 
_________________________________ 
 
______________________ 
Signature 
Date (DDMMMYYYY) 
 
 

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TABLE OF CONTENTS 
SUMMARY OF CHANGES ................................................................. Error! Bookmark not defined. 
AMC PROTOCOL SIGNATURE PAGE ......................................................................................... 2 
TABLE OF CONTENTS .................................................................................................................... 3 
LIST OF TABLES ............................................................................................................................... 5 
PROTOCOL ROSTER ....................................................................................................................... 6 
CONTACT INFORMATION ............................................................................................................. 8 
PROTOCOL SYNOPSIS .................................................................................................................... 9 
PROTOCOL SCHEMA .................................................................................................................... 10 
LIST OF ABBREVIATIONS ........................................................................................................... 11 
1.0 
OBJECTIVES ........................................................................................................................ 12 
1.1 
Primary Objective ..................................................................................................12 
1.2 
Secondary Objectives.............................................................................................12 
1.3 
Exploratory Objectives ..........................................................................................12 
2.0 
BACKGROUND .................................................................................................................... 13 
2.1 
Introduction ............................................................................................................13 
2.2 
Study Design and Rationale ...................................................................................14 
3.0 
PARTICIPANT SELECTION ............................................................................................. 17 
3.1 
Eligibility Criteria ..................................................................................................17 
3.2 
Exclusion Criteria ..................................................................................................18 
3.3 
Number of Participants to be Enrolled...................................................................18 
4.0 
REGISTRATION PROCEDURES ..................................................................................... 19 
4.1 
Investigator and Research Associate Registration with CTEP ..............................19 
4.2 
Site Registration .....................................................................................................20 
4.3 
Participant Registration ..........................................................................................22 
5.0 
TREATMENT PLAN ........................................................................................................... 24 
5.1 
Duration of Follow-Up ..........................................................................................24 
6.0 
ADVERSE EVENTS: LIST AND REPORTING REQUIREMENTS ............................. 25 
7.0 
PHARMACEUTICAL INFORMATION ........................................................................... 26 
8.0 
CLINICAL AND LABORATORY EVALUATIONS AND DATA COLLECTION ..... 27 
8.1 
Screening................................................................................................................27 
8.2 
Enrollment Data Collection ...................................................................................27 
8.3 
Follow-up Evaluations ...........................................................................................29 

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8.4 
Final Evaluations, Off Study..................................................................................30 
9.0 
MEASUREMENT OF EFFECT .......................................................................................... 31 
10.0 
STATISTICAL CONSIDERATIONS ................................................................................. 32 
10.1 
Study Design/Endpoints.........................................................................................32 
10.2 
Sample Size/Accrual Rate ......................................................................................32 
10.3 
Analysis of Secondary Endpoint and Analysis ......................................................34 
10.4 
Exploratory Endpoints ...........................................................................................35 
10.5 
Data and Safety Monitoring Board Review ...........................................................36 
11.0 
ROLE OF DATA MANAGEMENT AND DATA REPORTING ..................................... 37 
11.1 
Study Oversight .....................................................................................................37 
11.2 
CRF Instructions ....................................................................................................37 
11.3 
Data Quality ...........................................................................................................37 
11.4 
Data Reporting .......................................................................................................37 
11.5 
Data Monitoring .....................................................................................................38 
12.0 
ETHICAL AND REGULATORY CONSIDERATIONS .................................................. 39 
12.1 
IRB Approval and Informed Consent ....................................................................39 
12.2 
Changes to the Protocol .........................................................................................39 
12.3 
Women and Minorities ..........................................................................................39 
13.0 
REFERENCES ...................................................................................................................... 41 
APPENDIX I: SCHEDULE OF EVALUATIONS ......................................................................... 42 
APPENDIX II: PERFORMANCE STATUS SCALES .................................................................. 43 
APPENDIX III: AMC DATA AND SAFETY MONITORING PLAN ........................................ 44 
 
 
 

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LIST OF TABLES 
Table 2-A: Model data collection ..............................................................................................15 
Table 9-A: Definitions for case classification and data reporting ..........................................31 
Table 10-A: Estimated case counts ...........................................................................................33 
Table 10-B: AMC domestic site annual numbers of cancers in PWH ..................................34 
Table 12-A: Accrual targets ......................................................................................................40 
 
 
 

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PROTOCOL ROSTER 
AMC Protocol #115 
Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the 
AIDS Malignancy Consortium 
 
Protocol Chair: 
Anna E. Coghill, PhD, MPH 
H. Lee Moffitt Cancer Center & Research 
Institute 
13131 U.S.F Magnolia Drive, MRC 
Tampa, FL 33623 
Tel: (813) 745-7147 
Email: anna.coghill@moffitt.org  
Protocol Statistician: 
Madhu Mazumdar, PhD 
Icahn School of Medicine at Mount Sinai 
1425 Madison Avenue, NY, NY  10029 
Tel: (212) 659-9558 
Fax: (212) 423-2998 
Email: Madhu.mazumdar@mountsinai.org  
 
Mayuri Jain, MPH 
Icahn School of Medicine at Mount Sinai 
1425 Madison Avenue, NY, NY  10029 
Tel: (212) 659-9635 
Email: mayuri.jain@mountsinai.org 
Protocol Co-Chair: 
Elizabeth Chiao, MD, MPH 
University of Texas MD Anderson Cancer 
Center 
1155 Pressler Street 
Unit 1340 for Epidemiology 
Houston, TX 77030 
Tel: 717-792-1860 
Email: EYChiao@mdanderson.org 
Data Management/Operations: 
AMC Operations and Data Management 
Center 
The Emmes Company, LLC 
401 N. Washington Street, Suite 700 
Rockville, MD 20850 
Tel: (301) 251-1161 
Fax: (240) 238-2842 
Email: amcpm@emmes.com 
AMC Patient Outcomes, Survivorship and 
Engagement Committee (POSEC) Chair: 
Thomas M. Atkinson, PhD 
Memorial Sloan Kettering Cancer Center 
Department of Psychiatry & Behavioral 
Sciences 
641 Lexington Ave., 7th Floor 
New York, NY 10022 
Tel:646-888-0089 
Fax: 212-888-2584 
Email: atkinsot@mskcc.org 
AMC Patient Outcomes, Survivorship and 
Engagement Committee (POSEC) Co-
Chair: 
David M. Aboulafia, MD 
Virginia Mason Medical Center 
Benaroya Research Institute 
Hematologist-Oncologist 
1100 Ninth Avenue, C2-HEM 
Seattle, WA 98101 
Tel: (206) 223-6193 
Email: hemdma@vmmc.org 

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Kaposi Sarcoma Working Group (KSWG) 
Member: 
Samantha Vogt, MD, MPH 
Johns Hopkins University 
Johns Hopkins University SOM 
4940 Eastern Ave, Rm 450 
Baltimore, MD 21224 
Tel: 410-283-2057 
Email: svogt2@jhmi.edu 
Hematologic Working Group (HMWG) 
Member: 
Erin G. Reid, MD, MS 
University of California, San Diego 
Moores UCSD Cancer Center 
3855 Health Sciences Drive, Room 2238 
La Jolla, CA 92093-0698 
Tel: (858) 353-1984 
Email: egreid@ucsd.edu 
 
 
 

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CONTACT INFORMATION 
For regulatory requirements: 
For patient enrollments: 
For data submission: 
Regulatory documentation must 
be submitted to the CTSU via 
the Regulatory Submission 
Portal. 
(Sign in at www.ctsu.org and 
select the Regulatory > 
Regulatory Submission.) 
Institutions with participants 
waiting that are unable to use 
the Portal should alert the 
CTSU Regulatory Office 
immediately at 1-866-651-2878 
to receive further instruction 
and support. 
Contact the CTSU Regulatory 
Help Desk at 1-866-651-2878 
for regulatory assistance. 
Refer to the patient enrollment 
section of the protocol for 
instructions on using the 
Oncology Patient Enrollment 
Network (OPEN). OPEN is 
accessed at 
https://www.ctsu.org/OPEN_SYS
TEM/ or https://OPEN.ctsu.org. 
Contact the CTSU Help Desk 
with any OPEN-related questions 
by phone or email 1-888-823-
5923, or 
ctsucontact@westat.com. 
 
Data collection for this study will 
be done exclusively through 
Medidata Rave. Refer to the data 
submission section of the protocol 
for further instructions. 
 
 
The most current version of the study protocol and all supporting documents must be downloaded from 
the protocol-specific page located on the CTSU members’ website (https://www.ctsu.org). Access to the 
CTSU members’ website is managed through the Cancer Therapy and Evaluation Program - Identity and 
Access Management (CTEP-IAM) registration system and requires log in with a CTEP-IAM username 
and password. 
Permission to view and download this protocol and its supporting documents is restricted and is based on 
person and site roster assignment housed in the CTSU Regulatory Support System (RSS). 
For clinical questions (i.e., patient eligibility) 
Contact the protocol team via email at amc-115protocolteam@emmes.com. 
For clinical data submission questions: 
AMC Operations and Data Management Center 
The Emmes Company, LLC 
Phone: (301) 251-1161 
Email: amc-115@emmes.com 
For non-clinical questions (i.e., unrelated to patient eligibility, treatment, or clinical data 
submission) Contact the CTSU Help Desk by phone or email: 
CTSU General Information Line – 1-888-823-5923, or ctsucontact@westat.com. All calls and 
correspondence will be triaged to the appropriate CTSU representative.  
 
 

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PROTOCOL SYNOPSIS 
Title: 
Use of a Screening Tool to Describe HIV-Related Cancer Burden 
and Patient Characteristics in the AIDS Malignancy Consortium  
Accrual Target: 
A minimum of 360 and maximum of 720 participants  
Regulatory Status:  
Non-Interventional 
Population: 
Participants with a dual diagnosis of both cancer (current or 
diagnosed within 5 years) and underlying HIV infection, who 
present for care at AMC domestic sites.  
Regimen: 
Participants will be identified via screening of electronic medical 
records or institutional databases. All eligible participants will 
have one visit for the collection of broad demographic and 
clinical data. Participants initiating or receiving ongoing 
treatment for their cancer will attend a single follow-up 
visit. Data collection at study visits will occur via survey 
procedures and/or medical record review. 
Anticipated Trial 
Duration: 
Approximately 3 years for accrual and follow-up 
Primary Objective: 
To estimate the number of cancers in people with HIV (PWH) 
who present for care at domestic AMC sites  
Secondary Objectives: 
To characterize participants that are eligible but not enrolled onto 
AMC clinical trials to understand site-specific and trial-specific 
accrual barriers 
Exploratory Objectives: 
1. To standardize and expand the quantity and quality of 
sociodemographic and cancer diagnostic and treatment 
characteristics 
collected 
for 
PWH 
receiving 
care 
at domestic AMC sites. 
2. To describe cancer patient health-related QOL for PWH at 
domestic AMC sites using validated tools: European 
Organization for Research and Treatment of Cancer Quality 
of Life Questionnaire [EORTC QLQ-C30] and Supportive 
Care Needs Survey Short Form 34 [SCNS-SF34].  
 
 

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PROTOCOL SCHEMA 
 
 
 
 
Individuals with HIV who were diagnosed with or 
treated for cancer within the last 5 years.at domestic 
AMC sites 
Consent to participate (target 
enrollment 360-720) 
Metastatic or locally 
advanced cancer 
1.
Assess eligibility for 
open AMC trials 
2.
Collection of 
demographic data 
3.
Administer optional 
QOL surveys 
Prior cancer (diagnosed or 
treated within 5 years) but 
not currently on treatment 
other than ART or 
maintenance therapy 
1.
Assess general criteria 
for AMC trials (e.g., 
CD4 count) 
2.
Collection of 
demographic data 
3.
Administer optional 
QOL surveys 
New, primary or recurrent 
cancer 
1.
Assess eligibility for 
open AMC trials 
2.
Collection of 
demographic data 
3.
Administer optional 
QOL surveys 
Return for ~12-week follow-up 
1.
Assess vital status 
2.
Determine if planned cancer 
treatment was initiated 
3.
Administer optional follow-up QOL 
surveys 

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LIST OF ABBREVIATIONS 
AE 
Adverse event 
AIDS 
Acquired immunodeficiency syndrome 
AMC 
AIDS Malignancy Consortium 
ART 
Antiretroviral therapy 
CBC 
Complete blood count 
CDC 
Centers for Disease Control and Prevention 
CDUS 
Clinical Data Update System 
CRF 
Case report form 
CTEP 
Cancer Therapy Evaluation Program 
CTEP-AERS 
Cancer Therapy Evaluation Program Adverse Event Reporting System 
DSMB 
Data and Safety Monitoring Board 
ECOG 
Eastern Cooperative Oncology Group 
EORTC-QLQ 
European Organization for Research and Treatment of Cancer Quality of 
Life Questionnaire 
FDA 
Food and Drug Administration 
HIV 
Human immunodeficiency virus 
HPV 
Human papillomavirus 
IRB 
Institutional review board 
IND 
Investigational new drug 
NCI 
National Cancer Institute 
ODMC 
Operations and data management center 
PWH 
People with HIV 
POSEC 
Patient Outcomes, Survivorship, and Engagement Committee 
PrEP 
Pre-exposure Prophylaxis 
PROs 
Patient-Reported Outcomes 
QOL 
Quality of Life 
RNA 
Ribonucleic acid 
SAE 
Serious adverse event 
SCNS-SF34 
Supportive Care Needs Survey Short Form 34 
SES 
Socioeconomic Status 
 
 

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1.0 
OBJECTIVES 
1.1 
Primary Objective 
To estimate the number of cancers in PWH who present for care at domestic AMC sites 
1.2 
Secondary Objectives 
1.2.1 To characterize participants that are eligible but not enrolled onto AMC trials to 
understand site-specific and trial-specific accrual barriers, particularly for minority 
and underserved populations. 
1.3 
Exploratory Objectives 
1.3.1 To standardize and expand the quantity and quality of sociodemographic (e.g., 
racial/ethnic distribution, SES), HIV-related [e.g., Antiretroviral Therapy 
(ART) medications, co-morbidities], and cancer diagnostic and treatment 
characteristics collected for PWH receiving care at domestic AMC sites. 
1.3.2 To describe cancer patient health-related Quality of Life (QOL) for PWH at 
domestic AMC sites using validated tools: European Organization for Research and 
Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30] and 
Supportive Care Needs Survey Short Form 34 [SCNS-SF34]. 
 
 

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2.0 
BACKGROUND 
2.1 
Introduction 
Accrual of adults onto cancer clinical trials is challenging, and the cancer burden in the 
U.S. HIV population is growing to include a broader spectrum of both AIDS-defining 
and age-related, non-AIDS-defining cancers [1]. The objective of this protocol is to collect 
high-quality data that will address both trends. 
Fewer than 5% of U.S. adult cancer patients, and even fewer affected by both cancer and 
HIV/AIDS, enroll onto clinical trials. Research groups and government-sponsored 
organizations increasingly have focused on engaging communities to participate in cancer 
clinical trials. To broaden the understanding of characteristics of adults screened for, and 
those opting out of, NCI-sponsored cancer clinical trials, NCI Community Oncology 
Research Program (NCORP) developed a clinical trials screening tool (NCORP DCP-
001). AIDS Malignancy Consortium (AMC) clinical trials share similar challenges to the 
NCI trials described in NCORP DCP-001 [2], so screening tools to identify consistent 
barriers to participation for people living with HIV (PWH), who have historically been 
under-represented in clinical trials, are urgently needed across the AMC. The AMC 
preliminarily examined patient-level characteristics and perceptions that influenced 
decision-making about trial participation for 67 patients diagnosed with anal cancer or 
high-grade anal intraepithelial neoplasia [3]. Of those 67 participants, most were male 
(92.5%) non-Hispanic white (89.5%) adults (48.3 years old on average); most learned 
about AMC clinical trials from a medical provider (98.5%); and most (73.1%) expressed 
little general knowledge about clinical trials. Participants recommended system-level 
changes to accelerate patient access to clinical trials. Participants further underscored the 
need to address knowledge barriers to clinical trial participation. This protocol will follow-
up on these recommendations by proposing an AMC effort across all domestic sites to 
identify 
patient 
demographic 
(e.g., 
race/ethnicity), 
socioeconomic 
(e.g., 
homelessness/insurance status), and cancer-related (e.g., extent of disease) features 
associated with AMC clinical trial participation. This approach represents a large 
expansion beyond those preliminary data published from AMC-S006 by allowing 
enrollment across all domestic AMC sites, including all cancer types and AMC scientific 
working groups in data collection, and obtaining valuable information from 
not only participants who choose to enroll but, perhaps more importantly, from 
participants who present to AMC sites and are eligible for an open trial but who opt out of 
participation. 
In 2019, the AMC implemented a screening and prospective observational cohort protocol 
in Latin America (AMC-S008), with the goal of estimating the number of HIV-associated 
cancers of various types presenting at participating AMC clinical sites in the region. That 
protocol captures broad demographic and clinical data to generate further clinical treatment 
outcome hypotheses and research questions within the AMC international portfolio. The 
effort proposed here would represent the first such protocol focused on 
uniform prospective cancer patient data collection across AMC domestic sites. 
In summary, this protocol will implement a screening tool at domestic AMC sites that will 
capture cancer patterns in PWH, as well as broad demographic, cancer/clinical, and quality 

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of life (QOL) data from participants to generate future research questions and design 
efforts to improve AMC clinical trial participation. 
2.2 
Study Design and Rationale 
Rationale: Collection of expanded patient demographics and clinical information to include 
socioeconomic status (SES), method of diagnoses, and engagement in recommended 
oncology care is one way to enhance our ability to evaluate both the full patient population 
served at AMC domestic sites and to identify factors influencing participation in AMC 
clinical trials. This includes features of both participants who are potentially eligible but 
elect not to screen for trials and participants who are screened but deemed ineligible. 
Understanding characteristics of those presenting for care at AMC sites is critical to inform 
the design of future AMC cancer prevention and treatment efforts and assessment of 
feasibility of proposed trials to make informed decisions for resource allocation. In 
addition, this information will be invaluable in informing survivorship programs for PWH 
and cancer. 
Capturing patient health-related quality of life (QOL) experiences via patient-reported 
outcomes (PROs), is essential; thus, in 2020 the AMC formed the Patient Outcomes, 
Survivorship, and Engagement Committee (POSEC) to ensure that this data is documented 
in AMC trials using validated, culturally appropriate PRO tools that are of minimal burden 
to trial participants. Accordingly, this protocol will include an optional, brief 
PRO/QOL needs 
assessment 
that 
will 
allow for 
a 
better 
understanding 
of whether participant PRO/QOL features are potential barriers to clinical trial 
enrollment. This will serve as the first widespread use of QOL data across the AMC, both 
fulfilling the mission of POSEC and building a foundation for future, longitudinal 
survivorship efforts led by POSEC in the AMC. 
In summary, anticipated outcomes of this observational protocol are as follows: 
• Identify patient and clinical features associated with AMC clinical trial participation 
• Capture a complete picture of cancer burden in PWH at domestic AMC sites to guide 
future clinical trial priorities 
• Establish a robust population science framework for high-quality data collection across 
AMC sites 
• Serve as the first protocol to build a foundation for future QOL-based and survivorship 
efforts across the domestic AMC 
Study Design: All PWH who present for care at participating AMC clinical trial sites with 
a diagnosis of cancer will be tracked on a screening list. Institutional review board (IRB) 
approvals will be obtained to allow screening of the electronic medical record or 
institutional databases to identify these participants, as well as approach them after 
identification for further data collection. After identification, eligible patients will be 
approached to provide consent and participate in the collection of broad demographic and 
clinical data. To facilitate patient recruitment, and due to the on-going COVID-19 
pandemic, remote consenting prior to further data collection will be allowed, within the 
guidelines provided by the NCI Central Institutional Review Board (NCI CIRB) policies 
(see 
https://www.ncicirb.org/announcements/remote-consent-procedures-revised-faqs-

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due-covid-19). Such communications will be done via HIPAA-compliant methods such as 
telephone, personal delivery of documents, US postal service, REDCap, or other compliant 
electronic platform. The remote consent process will parallel the consent processed used 
for in-person consenting. The only difference will be the method(s) of communication and 
optional use of eSignatures, only if implemented according to NCI CIRB SOP section 
2.3.1.6. The study team will ensure that, as with in-person consenting, the participant is 
given sufficient opportunity to ask questions, is able to understand the nature of this study 
and what participation entails, and is provided a copy of the final, completed consent signed 
by all parties involved. 
This trial is a one visit study for those with history of malignancy diagnosed in the past 5 
years, including those with cancer currently in remission. There will be one follow-up visit 
for those initiating or receiving on-going treatment for their cancer. In all participants who 
consent to participate, data captured will include the following: 
Table 2-A: Model data collection  
Participant 
Characteristics  
Date of birth, biological sex, gender identity, race, ethnicity, height and 
weight  
Sociodemographic Socioeconomic status (e.g., ZIP code, housing status [homeless y/n]), health 
insurance (insured/uninsured, type if insured)  
Health Behaviors  
Tobacco use (type, exposure [pack/day, years use]), illicit drug use (ever, 
type, 
years 
exposure), 
alcohol 
use 
(ever, 
exposure 
[drinks/week], years exposure)  
Comorbid 
Conditions  
Hepatitis B and C co-infection, cardiovascular disease (y/n, type), psychiatric 
conditions (y/n, type), non-cancer pulmonary conditions (y/n, type), hepatic 
dysfunction, hematologic abnormalities, renal dysfunction, neurologic 
disorders, endocrine disorders (including thyroid disorders, and diabetes)  
HIV Care  
Current ART regimen, years of ART use, year of HIV diagnosis, history 
of opportunistic infections, recent HIV viral load and CD4+ T-cell count  
Status of Cancer 
Diagnosis  
New, primary or recurrent disease; current metastatic or locally advanced, 
inoperable cancer; history of malignancy diagnosed within 5 years / cancer 
currently in remission  
Cancer Details  
Cancer type, date cancer diagnosed, diagnosis methods (clinical, cytology, 
histology), pathology performed, date of pathology, staging, staging methods 
(clinical, radiographic, surgical), current ECOG Performance Status (PS), 
current laboratory (CBC) values, cancer treatment history (for metastatic 
tumors or disease in remission)  
Cancer Treatment 
Plan  
Planned treatment (e.g., chemotherapy versus radiation versus surgery 
versus antiretroviral 
therapy 
[ART] 
only 
versus best 
supportive 
care/watchful waiting), location of planned treatment, timeline of planned 
treatment (start date), if past diagnosis and treatment- end date, enrollment in 
clinical trial, and clinical trial details  

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Quality of 
Life/Survivorship  
European Organization for Research and Treatment of Cancer Quality of Life 
Questionnaire (EORTC QLQ-C30: Global health status, physical 
functioning, role functioning, emotional functioning, cognitive functioning, 
social functioning, fatigue, nausea and vomiting, pain, dyspnea, insomnia, 
appetite loss, constipation, diarrhea, financial toxicity) and Supportive Care 
Needs Survey Short Form 34 (SCNS-SF34: psychological needs, health 
system and information needs, physical and daily living needs, patient care 
and support needs, sexuality needs) 
For participants initiating therapy or currently under treatment, a short interval follow-up 
(12 weeks ± 2 weeks), will be used to ascertain vital status, state of planned cancer 
therapy (initiated as planned versus delayed initiation, no initiation, or initiation of 
alternate therapy instead of planned therapy) and any reasons for therapy not being initiated 
as planned (e.g., comorbidity, cancer progression, patient preference, insurance denial), 
and optional quality of life changes between initial registration and this short interval 
follow-up. An approximate 12-week follow-up assessment is expected to coincide with 
planned treatments/clinical follow-up and therefore minimize unnecessary clinic visits that 
could increase patient burden. The data collected at this later time point will be limited, as 
the intent capture is to ascertain the relationship between planned therapy and therapy 
received, as well as any QOL changes that coincide with start of therapy and/or clinical 
trial enrollment. 
 
 

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3.0 
PARTICIPANT SELECTION 
A rostered AMC investigator (CTEP-registered physician investigator or non-physician 
investigator) must document that each protocol participant meets all stated eligibility 
criteria. Participating sites must have documentation that each eligibility requirement is 
satisfied prior to participant enrollment. In compliance with CTEP policy, no exceptions 
to eligibility criteria will be granted under any circumstance. 
NOTE: Institutions may use this section of the protocol as an eligibility checklist for source 
documentation if it has been reviewed, signed, and dated before registration/randomization 
by the study investigator. If used as source documentation, this checklist must be printed, 
the investigator must check each item to document their assessment that the participant 
meets each eligibility criterion, and the completed checklist must be maintained in the 
participant’s chart. 
Participant ID Number: AMC-115 - ___ ___ ___ - ___ ___ ___ 
Participant Initials (L, F, M [optional]): ___ ___ ___ 
NOTE: All questions regarding eligibility should be directed to the study chair. 
3.1 
Eligibility Criteria 
____ 3.1.1 Participant can understand and is willing to sign a written informed consent 
document. 
____ 3.1.2 HIV positive. Documentation of HIV-1 infection by means of any one of the 
following: 
• Documentation of an HIV diagnosis in the medical record by a licensed health 
care provider; 
• Documentation of receipt of antiretroviral therapy (ART) (i.e., at least two 
different medications that do not constitute a prescription for pre-exposure 
prophylaxis [PrEP]) by a licensed health care provider. Documentation may be 
a record of an ART prescription in the medical record, a written prescription in 
the name of the participant for ART, or pill bottles for ART with a label showing 
the participant’s name; 
• HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 
RNA copies/mL; 
• Any licensed HIV screening antibody and/or HIV antibody/antigen 
combination assay confirmed by a second licensed HIV assay such as a HIV-1 
Western blot confirmation or HIV rapid multispot antibody differentiation 
assay. 
Note: The term “licensed” refers to a kit that has been certified or licensed by an 
oversight body within the participating country and validated internally (e.g., U.S. 
FDA). 
WHO (World Health Organization) and CDC (Centers for Disease Control and 
Prevention) guidelines mandate that confirmation of the initial test result must use 
a test that is different from the one used for the initial assessment. A reactive initial 

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rapid test should be confirmed by either another type of rapid assay, or an E/CIA 
that is based on a different antigen preparation and/or different test principle (e.g., 
indirect versus competitive), a Western blot, or a plasma HIV-1 RNA viral load. 
____ 3.1.3  Patient was diagnosed with or treated for cancer within the last 5 years. Participants 
will qualify under one of three categories: 
• New, primary or recurrent diagnosis –Considering or currently receiving cancer 
treatment  
• Metastatic or locally advanced cancer – This includes cases for which there are 
no current definitive therapy options for cure (i.e., inoperable) but may be 
considered for non-standard / non-curative therapies.  
• Prior diagnosis (within 5 years), in remission – Not currently on cancer 
treatment other than ART or maintenance therapy.  
____ 3.1.4 Age ≥ 18 years. 
____ 3.1.5 Participant presents to an AMC domestic clinical trial site for either clinical care or 
research. 
3.2 
Exclusion Criteria 
Participants who do not fulfill the criteria as listed in Section 3.1 above are ineligible. 
3.3 
Number of Participants to be Enrolled 
NIH policy requires that women and members of minority groups and their subpopulations 
be included in all NIH-supported biomedical and behavioral research projects involving 
NIH-defined clinical research unless a clear and compelling rationale and justification 
establishes to the satisfaction of the funding Institute & Center (IC) Director that inclusion 
is inappropriate with respect to the health of the participants or the purpose of the research.  
3.3.1 Proposed sample size 
This study will enroll a minimum of 360 participants and a maximum of 720 
participants. 
3.3.2 Accrual rate 
Approximately 10-20 participants per month across domestic AMC sites. 
 
 

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4.0 
REGISTRATION PROCEDURES 
4.1 
Investigator and Research Associate Registration with CTEP 
This study is non-interventional and is therefore exempt from IND requirements. However, 
the following registration policy must be followed in accordance with Cancer Therapy 
and Evaluation Program (CTEP) policy. 
Food and Drug Administration (FDA) regulations and National Cancer Institute (NCI) 
policy require all individuals contributing to NCI-sponsored trials to register and to renew 
their registration annually. To register, all individuals must obtain a CTEP Identity and 
Access Management (IAM) account at https://ctepcore.nci.nih.gov/iam. In addition, 
persons with a registration type of Investigator (IVR), Non-Physician Investigator 
(NPIVR), or Associate Plus (AP) (i.e., clinical site staff requiring write access to Oncology 
Patient Enrollment Network (OPEN), Rave, or acting as a primary site contact) must 
complete their annual registration using CTEP’s web-based Registration and Credential 
Repository (RCR) at https://ctepcore.nci.nih.gov/rcr. 
RCR utilizes five registration types. 
• IVR: MD, DO, or international equivalent, 
• NPIVR: advanced practice providers (e.g., NP or PA) or graduate level researchers 
(e.g., PhD), 
• AP: clinical site staff (e.g., RN or CRA) with data entry access to CTSU applications 
(e.g., Roster Update Management System [RUMS], OPEN, Rave), 
• Associate (A): other clinical site staff involved in the conduct of NCI-sponsored trials, 
and 
• Associate Basic (AB): individuals (e.g., pharmaceutical company employees) with 
limited access to NCI-supported systems. 
RCR requires the following registration documents: 
Documentation Required 
IVR 
NPIVR AP 
A 
AB 
FDA Form 1572 
✔ 
✔ 
 
 
 
Financial Disclosure Form 
✔ 
✔ 
✔ 
 
 
NCI Biosketch (education, training, employment, 
license, and certification) 
✔ 
✔ 
✔ 
GCP training 
✔ 
✔ 
✔ 
Agent Shipment Form (if applicable) 
✔ 
CV (optional) 
✔ 
✔ 
✔ 
An active CTEP-IAM user account and appropriate RCR registration is required to access 
all CTEP and Cancer Trials Support Unit (CTSU) websites and applications. In addition, 
IVRs and NPIVRs must list all clinical practice sites and Institutional Review Boards 
(IRBs) covering their practice sites on the FDA Form 1572 in RCR to allow the following: 
• Addition to a site roster, 
• Assign the credit or consenting (IVR only) tasks in OPEN, 

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• Act as the site-protocol Principal Investigator (PI) on the IRB approval, and 
• Assign the Clinical Investigator (CI) role on the AMC Delegation of Tasks Log (DTL). 
In addition, all investigators act as the Site-Protocol PI, consenting, or as the CI on the 
AMC DTL must be rostered at the enrolling site with a participating organization (i.e., 
Alliance). 
Additional 
information 
is 
located 
on 
the 
CTEP 
website 
at 
https://ctep.cancer.gov/investigatorResources/default.htm. 
For 
questions, 
please 
contact the RCR Help Desk by email at RCRHelpDesk@nih.gov. 
4.2 
Site Registration 
All U.S. based sites must be members of the NCI Central Institutional Review Board (NCI 
CIRB). Sites participating with the NCI Central Institutional Review Board (NCI CIRB) 
must submit the Study Specific Worksheet for Local Context (SSW) to the CIRB using 
IRBManager to indicate their intent to open the study locally. The NCI CIRB’s approval of 
the SSW is automatically communicated to the CTSU Regulatory Office, but sites are 
required to contact the CTSU Regulatory Office at CTSURegPref@ctsu.coccg.org or 
amcpm@emmes.com to establish site preferences for applying NCI CIRB approvals 
across their Signatory Network. Site preferences can be set at the network or protocol level. 
Questions about establishing site preferences can be addressed to the CTSU Regulatory 
Office by emailing the email address above or calling 1-888-651-CTSU (2878), or by 
contacting the AMC ODMC (see protocol roster). 
In addition, the Site-Protocol PI (i.e., the investigator on the IRB approval) must meet the 
following five criteria to complete processing of the IRB approval record: 
• Holds an active CTEP registration status, 
• and on the AMC site roster, 
• If using NCI CIRB, rostered on the NCI CIRB Signatory record, 
• Includes the IRB number of the IRB providing approval in the Form FDA 1572 in the 
RCR profile, and 
• Holds the appropriate CTEP registration type for the protocol. 
Additional Requirements 
Additional requirements to obtain an approved site registration status include: 
• An active Federal wide Assurance (FWA) number, 
• An active roster affiliation with the Lead Protocol Organization (LPO) or a Participating 
Organization, and 
• Compliance with all protocol-specific requirements (PSRs). 
4.1.1 Downloading regulatory documents 
Download the site registration forms from the protocol-specific page located on the 
CTSU members’ website. Permission to view and download this protocol and its 
supporting documents is restricted based on person and site roster assignment. To 

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participate, the institution and its associated investigators and staff must be 
associated with the LPO or a Participating Organization on the protocol. 
• Log on to the CTSU members’ website (https://www.ctsu.org) using your 
CTEP-IAM username and password, 
• Click on Protocols in the upper left of your screen 
o Enter the protocol number in the search field at the top of the protocol tree, 
or 
o Click on the By Lead Organization folder to expand, then select AMC, and 
protocol number AMC-115, 
• Click on Documents, select Site Registration, and download and complete the 
forms provided. (Note: For sites under the CIRB initiative, IRB data will load 
automatically to the CTSU as described above.) 
4.1.2 Protocol-specific requirements for site registration 
Upon site registration approval in RSS, the enrolling site may access OPEN to 
complete enrollments. The enrolling site will select their credentialed provider 
enrolling the subject in the OPEN credentialing screen and will answer enrollment 
questions based on the eligibility checklist. 
4.1.3 Submitting regulatory documents 
Submit required forms and documents to the CTSU Regulatory Office via the 
Regulatory Submission Portal on the CTSU website. 
To access the Regulatory Submission Portal, log on to the CTSU members’ website 
 Regulatory  Regulatory Submission. 
Institutions with participants waiting that are unable to use the Regulatory 
Submission Portal should alert the CTSU Regulatory Office immediately at 1-866-
651-2878 in order to receive further instruction and support. 
Delegation of tasks log (DTL) 
Each site must complete a protocol-specific registration packet, including an AMC 
DTL using the provided AMC template or local equivalent. The Clinical 
Investigator (CI) is required to review and sign the DTL prior to the site receiving 
an approved site registration status and enrolling participants to the study. The 
AMC DTL template is provided in the protocol registration packet for this protocol, 
located on the AMC Operations web site at www.AIDSCancer.org. Any individual 
at the enrolling site on a participating roster may initiate the site DTL. Instructions 
on completing the DTL are embedded in the AMC DTL template. 
4.1.4 The AMC DTL must be updated contemporaneously as personnel are added or 
removed and/or study roles and delegated tasks change. Changes must be approved 
by the CI, and documented by his/her initials and date, before they are 
implemented. 
4.1.5 Checking site registration status 

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You can verify your site’s registration status on the members’ side of the CTSU 
website. 
• Log on to the CTSU members’ website 
• Click on Regulatory at the top of your screen 
• Click on Site Registration 
• Enter your 5-character CTEP Institution Code and click on Go 
Note: The status shown only reflects institutional compliance with site registration 
requirements as outlined above. It does not reflect compliance with protocol 
requirements for individuals participating on the protocol or the enrolling 
investigator’s status with the NCI or their affiliated networks. 
4.3 
Participant Registration 
Sites must have this protocol approved by the NCI Central Institutional Review Board 
(CIRB) and be registered for study participation with the AMC Operations and Data 
Management Center (ODMC) before they may enroll participants. 
After an informed consent form has been signed by the participant and it has been 
determined that the participant is eligible, the participant must be registered on-line via the 
Oncology Patient Enrollment Network (OPEN). 
4.3.1 OPEN 
The Oncology Patient Enrollment Network (OPEN) is a web-based registration 
system available on a 24/7 basis. OPEN is integrated with CTSU regulatory and 
roster 
data 
and 
with 
the 
Lead 
Protocol 
Organization 
(LPOs) 
registration/randomization systems for retrieval of participant registration 
assignments. OPEN will populate the patient enrollment data in NCI’s clinical data 
management system, Medidata Rave. 
Requirements for OPEN access: 
• A valid CTEP-IAM account. 
• To perform enrollments or request slot reservations: Be on the AMC roster, or 
Participating Organization roster with the role of Registrar. Registrars must 
hold a minimum of an AP registration type. 
• If a DTL is required for the study, the registrar(s) must hold the OPEN Registrar 
task on the DTL for the site. 
• Have an approved site registration for a protocol prior to patient enrollment. 
To assign an Investigator (IVR) or Non-Physician Investigator (NPIVR) as the 
crediting, consenting, , or receiving investigator for a patient transfer in OPEN, the 
IVR or NPIVR must list the IRB number used on the site’s IRB approval on their 
Form FDA 1572 in RCR. If a DTL is required for the study, the IVR or NPIVR 
must be assigned the appropriate OPEN-related tasks on the DTL. 
Prior to accessing OPEN, site staff should verify the following: 

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• Patient has met all eligibility criteria within the protocol stated timeframes, and 
• All participants have signed an appropriate consent form and HIPAA 
authorization form (if applicable). 
Note: The OPEN system will provide the site with a printable confirmation of 
registration information. Please print this confirmation for your records. 
Access OPEN at https://open.ctsu.org or from the OPEN link on the CTSU 
website https://www.ctsu.org. Further instructional information is in the OPEN 
section of the AMC members’ website at www.AIDSCancer.org. For any 
additional questions, contact the AMC ODMC (contact information in protocol 
roster). 
4.3.3 OPEN questions 
Further instructional information on OPEN is provided on the OPEN link of the 
CTSU website at https://www.ctsu.org or at https://open.ctsu.org. For any 
additional questions contact the CTSU Help Desk at 1-888-823-5923 or 
ctsucontact@westat.com. 
 
 

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5.0 
TREATMENT PLAN 
This is a non-interventional study. Please refer to the Study Design (Section 2.3), Clinical 
and laboratory evaluations (Section 8), and Measurement of Effect (Section 9) for a 
description of the trial procedures. 
5.1 
Duration of Follow-Up 
For participants not currently receiving cancer therapy, participation only involves the 
initial encounter for study data collection. For participants initiating therapy or currently 
under treatment, a short-interval follow-up will occur at 12 Weeks (± 2 Weeks). This is 
expected to coincide with planned treatments/clinical follow-up and therefore minimize 
unnecessary clinic visits that could increase participant burden (see Section 8.3 for 
requirements).  
 

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6.0 
ADVERSE EVENTS: LIST AND REPORTING REQUIREMENTS 
As this study is non-interventional that focuses on data collection with limited follow-up, 
no adverse event data will be collected. 
 
 

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7.0 
PHARMACEUTICAL INFORMATION 
Not applicable (non-interventional study). 
 
 

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8.0 
CLINICAL AND LABORATORY EVALUATIONS AND DATA COLLECTION 
Evaluations required for this protocol are enumerated below and summarized in the 
Schedule of Events in Appendix I. 
8.1 
Screening 
All PWH who present for care at participating AMC clinical trial sites with a histologically 
confirmed diagnosis of cancer (within the past 5 years) will be tracked on a screening list. 
Eligibility will be assessed for each patient on the list, and if they are determined eligible, 
they will be approached to participate in AMC-115. 
To determine the types of cancer cases that present to the clinical sites, all participants 
presenting at these sites have a minimum set of de-identified data collected. This minimal 
risk data collection will only include the participant’s age, sex at birth, race/ethnicity, and 
type of cancer and will be performed prior to formal consent. Data collected during 
screening will be maintained separately from data on enrolled cases. This data will be 
compared to the total number of enrolled participants at each site to estimate the proportion 
of participants who consent to participate in this trial. 
The protocol chair has established a set of IT logic codes that can be applied to electronic 
health record (EHR) systems to automate screening for “HIV status” among cancer 
patients. This is critical as it (1) makes the ascertainment of PWH and cancer uniform 
across participating domestic AMC sites and (2) reduces physician and study coordinator 
burden by leveraging the electronic medical record and automating the search. To ensure 
that this IT-based approach can be implemented across domestic AMC sites, the feasibility 
survey included a question specifically about the ability of sites to search their electronic 
medical record systems for HIV-specific disease codes.  
8.2 
Enrollment Data Collection 
Following informed consent, additional, identifiable data will be collected, including: 
8.2.1 Patient characteristics: Date of birth, biological sex, gender identity, race, ethnicity, 
height and weight 
8.2.2 Sociodemographic: Socioeconomic status (e.g., ZIP code, housing status [homeless 
y/n, categories for frequency of housing insecurity]), health insurance 
(insured/uninsured, type if insured) 
8.2.3 Health behaviors: Tobacco use (type, exposure [pack/day, years use]), illicit drug 
use (ever, type, years exposure), alcohol use (ever, exposure [drinks/week], years 
exposure) 
8.2.4 Comorbid conditions: Hepatitis B and C co-infection, cardiovascular disease (y/n, 
type), psychiatric conditions (y/n, type), non-cancer pulmonary conditions (y/n, 
type), hepatic dysfunction, hematologic abnormalities, renal dysfunction, 
neurologic disorders, endocrine disorders (including thyroid disorders, and 
diabetes) 
8.2.5 HIV care: Current ART regimen, years of ART use, year of HIV diagnosis, history 
of opportunistic infections, most recent HIV viral load and CD4+T-cell count 
relative to participant visit). 

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8.2.6 Status of cancer diagnosis (one of the following): 
• New diagnosis, pre-treatment phase 
• New diagnosis, treatment phase 
• Prior diagnosis, in remission (within 5 years of initial diagnosis or treatment) 
• Prior diagnosis, recurrent, pre-treatment phase 
• Prior diagnosis, recurrent, treatment phase 
• Prior diagnosis, recurrent, no treatment planned 
8.2.7 For participants with a new diagnosis (pre-treatment or treatment), the following 
will be collected: 
• Cancer type, date of cancer diagnosis, method of diagnosis (clinical, cytology, 
histology), type of pathology performed (Hematoxylin and Eosin, 
immunohistochemistry, other), date of pathology, staging, staging methods 
(clinical, radiographic, surgical), date(s) of staging, current ECOG Performance 
Status (PS), current laboratory values (this would include complete blood count, 
renal and liver function, electrolytes  
• Cancer treatment plan: Detailed planned or current treatment. This should 
encompass surgical interventions, radiotherapy, and chemotherapy (agent 
names), including dates of planned or current therapy, and whether cancer care 
is being received or will occur at the enrolling institution. 
8.2.8 For participants with a prior diagnosis in remission, the following will be collected: 
• Cancer history: Cancer type, date of diagnosis, prior method of diagnosis 
(cytology, histology), pathology performed, date of pathology, staging, staging 
methods (clinical, radiographic, surgical), current ECOG PS. Records from a 
prior diagnosis/treatment should be requested, but if they are unavailable, 
participant report will be sufficient.  
• Current method of post-treatment surveillance (clinical, laboratory, 
radiographic), and current schedule of follow-up with this center. 
• Prior cancer treatment. This should encompass surgical interventions, 
radiotherapy, and chemotherapy. Records from a prior diagnosis/treatment 
should be requested, but if they are unavailable, participant report will be 
sufficient. 
8.2.9 For participants with a prior diagnosis, recurrent (pre-treatment, treatment, or no 
planned treatment) the following will be collected: 
• Initial cancer type, date of diagnosis 
• Cancer history: prior method of diagnosis (cytology, histology), pathology 
performed, date of pathology, staging, staging methods (clinical, radiographic, 
surgical), date(s) of staging. Records from a prior diagnosis/treatment should 
be requested, but if they are unavailable, participant report will be sufficient. 

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• Prior cancer treatment. This should encompass surgical interventions, 
radiotherapy, and chemotherapy. Records from a prior diagnosis/treatment 
should be requested, but if they are unavailable, participant report will be 
sufficient. 
• Current date of cancer diagnosis, method of diagnosis (clinical, cytology, 
histology), pathology performed, date of pathology, staging, staging methods 
(clinical, radiographic, surgical), date(s) of staging, current ECOG Performance 
Status (PS), current laboratory values (this would include complete blood count, 
renal and liver function, electrolytes). 
• IF THERAPY IS PLANNED OR UNDERWAY: Detailed planned or current 
treatment. This should encompass surgical interventions, radiotherapy, and 
chemotherapy, dates of planned or current therapy, and whether cancer care is 
being received or will occur at the enrolling institution. 
• IF NO THERAPY IS PLANNED: Reason for no further therapy, e.g., if the 
decision for no therapy is based on lack of options for treatment, lack of benefit 
of further treatment, or participant choice not to pursue further treatment. 
8.2.10 Optional QoL questionnaires will be administered in the following languages 
understandable to the participant: English, Spanish, Italian, Chinese, Dutch, 
Amharic and Turkish. The QOL questionnaires have been validated for use in these 
languages and participants who do not speak English, Spanish, Italian, Chinese, 
Dutch, Amharic and Turkish will not be asked to complete these optional 
questionnaires. These questionnaires are optional for study participation: 
• EORTC QLQ-C30: Global health status, physical functioning, role functioning, 
emotional functioning, cognitive functioning, social functioning, fatigue, 
nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, 
diarrhea, financial toxicity 
• SCNS-SF34: psychological needs, health system and information needs, 
physical and daily living needs, patient care and support needs, sexuality needs 
8.2.11 Biospecimens: 
• As collection of HIV viral load or CD4 are standard of care for patients with 
HIV and cancer, HIV viral load and/or CD4 will be taken from the medical 
record from the date closest to the participant’s visit. Biospecimens will not be 
collected as part of this study. 
8.3 
Follow-up Evaluations 
For participants initiating therapy or currently under treatment, a short interval follow-up 
will occur at 12 Weeks (± 2 Weeks). This is expected to coincide with planned 
treatments/clinical follow-up and therefore minimize unnecessary clinic visits that could 
increase participant burden. 
8.3.1 Vital status 
8.3.2 State of planned cancer therapy (initiated as planned versus delayed initiation, no 
initiation, or initiation of alternate therapy in place of planned therapy) 

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8.3.3 Optional QoL questionnaires as described in Section 8.2.10: 
• EORTC QLQ-C30 
• SCNS-SF34 
8.4 
Final Evaluations, Off Study 
Participants who are not currently receiving any treatment will not complete a follow-up 
evaluation. Therefore, the Off Study Summary Form should be completed in iMedidata 
Rave after completing the Enrollment Data Collection in Section 8.2. 
For participants who are planning to initiate therapy or are currently under treatment, at the 
completion of all follow-up evaluations described in Section 8.3, the Off Study Summary 
Form should be completed in iMedidata Rave. 
 
 

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9.0 
MEASUREMENT OF EFFECT 
This is a non-interventional protocol. 
The following definitions will be employed for case classification and data reporting for 
the primary protocol objective, to estimate the number of cancers in PWH who present for 
care at domestic AMC sites: 
Table 9-A: Definitions for case classification and data reporting 
Site-specific 
frequency of 
primary cancer 
cases 
Total number of participants that present to the site with a first 
diagnosis of cancer. This encompasses cases that are in the period 
from histologically proven cancer to initiation of planned first-line 
therapy, as well as cases already receiving the planned first-line 
therapy for primary disease. 
Site-specific 
frequency of 
recurrent cancer 
cases 
Total number of participants that present to the site with a diagnosis 
of cancer within the last 5 years. This includes participants on 
surveillance, or best supportive care.  
Site-specific 
frequency of 
prior cancer 
cases 
Total number of participants that present to the site with a recurrent 
(i.e., non-primary) cancer diagnosis. This encompasses cases that are 
pre-treatment for recurrent disease, undergoing planned non-first-
line therapy, or cases for whom no anti-cancer therapy is planned, 
including due to metastatic or locally advanced, inoperable disease. 
Pre-treatment 
phase 
The period in which a participant has a histologically diagnosed 
cancer, with cancer-specific treatment planned but not yet initiated. 
Treatment phase 
The period in which the participant has started therapy for cancer. 
This can include surgery, radiation, and/or chemotherapy. This 
period completes when all planned therapy has been completed 
within a therapeutic encounter. 
First-line therapy All therapy performed as part of a treatment plan with a new/primary 
diagnosis of cancer, including surgery, radiotherapy, and 
chemotherapy, alone or in combination. 
No treatment 
planned 
The point at which no further active cancer treatments are planned. 
Initiation of best supportive care or palliative care.  

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10.0 
STATISTICAL CONSIDERATIONS 
10.1 
Study Design/Endpoints 
This is a non-interventional protocol. This study will utilize a prospective design to identify 
the frequency of new and existing cancer cases among PWH receiving care at AMC clinical 
trial sites. 
10.1.1 Primary endpoint 
The primary endpoint is to estimate the number of cancers in PWH who present for 
care at domestic AMC sites. These estimates will help to inform the target 
populations for subsequent AMC clinical trials. 
10.1.2 Primary endpoint analysis 
For each cancer group listed below, the number of new and existing cases per 
month will be estimated using a 95% Poisson confidence interval. Additionally, the 
distribution of cancer types will be computed as percentages and compared to the 
cancer type distribution in the HIV/AIDS Cancer Match (HACM) Study, a 
nationally representative HIV and cancer linkage database [4]. For reference, the 
HIV/AIDS Cancer Match (HACM) Study estimated that the proportion of 
participants with the following cancer types as: 
1. Solid organ tumors associated with human papillomavirus (HPV) infection = 
12.5% 
2. Solid organ tumors unrelated to HPV = 49.3% 
3. Kaposi sarcoma = 10.9% 
4. Hematologic malignancies = 27.3% 
10.2 
Sample Size/Accrual Rate 
10.2.1 Target accrual is 20 participants per month, with a target of 720 participants 
enrolled over 36 months. Because the primary objective’s focus is estimation, we 
note below in Table 10-A both the width of the 95% confidence intervals (CIs) for 
prevalence, and the accompanying estimated case counts, for the minimum and 
maximum target sample sizes of 360 and 720. For each cancer group, anticipated 
prevalence estimates are based on those observed in other national datasets (see 
Section 10.1.2 above). 95% CIs are computed using PASS 2021 software, utilizing 
a simple asymptotic estimation approach (i.e., a normal approximation to the 
binomial approach with a continuity correction.) 
 
 

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Table 10-A: Estimated case counts 
Cancer 
Types 
Sample Size of 360 
Sample Size of 720 
 
Prevalence 
Case Count 
Prevalence 
Case Count 
Solid Organ 
Tumors 
Associated 
with HPV  
12.5% (95% 
CI: 8.9-16.1%)  
45 cases (95% CI: 
32-58 cases) 
 
12.5% (95% CI: 
10.0-15.0%) 
90 cases (95% CI: 
72-108 cases) 
 
Solid Organ 
Tumors 
Unrelated to 
HPV  
49.3% (95% 
CI: 44.0-
54.6%) 
177 cases (95% 
CI: 158-197 
cases) 
49.3% (95% CI: 
45.6-53.0%) 
355 cases (95% 
CI: 328-382 
cases) 
Kaposi 
Sarcoma  
10.9% (95% 
CI: 7.5-14.3%)  
39 cases (95% CI: 
27-52 cases) 
 
10.9% (95% CI: 
8.6-13.2%) 
78 cases (95% CI: 
62-95 cases) 
 
Hematologic 
Malignancies  
27.3% (95% 
CI: 22.6-
32.0%)  
98 cases (95% CI: 
81-115 cases) 
27.3% (95% CI: 
24.0-30.6%) 
197 cases (95% 
CI: 173-220 
cases) 
One example of how this will translate into monthly enrollment targets is provided 
here: If 355 participants with solid organ tumors unrelated to HPV are to be enrolled 
across 36 months, or 9.9 such participants per month, the 95% CI would be 9.1-
10.6 cases (i.e., 9-11 participants) per month. 
10.2.2. The goal is to open this protocol at ≥ 75% of domestic AMC sites. Based 
on updated responses from 19 domestic AMC sites on the protocol-associated 
feasibility survey, 16 AMC domestic sites indicated that this study would be 
feasible to open. The table below (Table 10-B) includes results for 
those 16 domestic sites. Based on their estimates for annual number of cancers seen 
at their AMC site, we anticipate that this protocol will meet accrual targets. 
 
 

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Table 10-B: AMC domestic site annual numbers of cancers in PWH 
AMC Site 
Kaposi 
Sarcoma 
Heme 
Malignancies 
HPV+ Solid 
Tumors 
Non-HPV 
Solid 
Tumors 
Total Cancers 
LSUHSC  
10 
30 
10 
50 
100 
Anal Dysplasia 
Clinic MidWest 
0 
0 
1 
0 
1 
Penn  
25 
10 
10 
10 
55 
Wash U  
30 
10 
15 
30 
85 
Laser Surgery  
2 
3 
10 
0 
15 
MSK  
5 
8 
5 
5 
23 
Montefiore  
2 
15 
15 
15 
47 
Moffitt  
3 
20 
15 
20 
58 
Boston Medical 
Center  
8 
8 
15 
15 
46 
Virginia Mason  
7 
3 
4 
4 
18 
Miami Cancer 
Institute  
5 
30 
25 
25 
85 
George 
Washington  
2 
5 
10 
10 
27 
Puerto Rico  
2 
4 
4 
2 
12 
UCSF  
2 
1 
5 
3 
11 
UCSD  
32 
59 
23 
52 
166 
UNC  
4 
4 
2 
4 
14 
Total  
139 
210 
169 
245 
763 
The above estimates indicate that sites, including those with a history 
of consistent enrollment onto AMC trials and new sites added in current AMC 
grant years, see 763 cancer cases with underlying HIV infection each year. Even 
with a conservative patient participation rate for this minimal burden study, the 
protocol chairs deem the target accrual range (360-720) to be feasible. 
10.3 
Analysis of Secondary Endpoint and Analysis  
The secondary endpoint is the proportion of participants eligible for AMC trials who are 
successfully enrolled. 
For this calculation, the denominator will be computed based on PWH deemed eligible at 
each site, based only on AMC trials open at that respective site. 
For participants with active disease, each participant’s data will be evaluated to determine 
whether they meet minimal eligibility criteria for an AMC clinical trial open at 

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their respective domestic site, defined as meeting the following minimum eligibility 
criteria per the protocol: 
a. Cancer diagnosis including stage and histology  
b. Age range specified in the protocol for which the patient is being screened 
c. Indication for the study intervention (e.g., symptom, toxicity) 
These data will be compared to the actual number of participants enrolled onto AMC 
trials open at each site to estimate the proportion of trial-eligible participants who 
enroll. For participants with a history of malignancy diagnosed within the past 5 years / 
cancer currently in remission, each patient’s performance status and HIV metrics (CD4+ 
T-cell count and HIV viral load) will be evaluated to determine whether they meet 
general levels that are consistent with eligibility criteria for prior AMC clinical trials. To 
characterize participants who are eligible but not enrolled onto AMC trials, participant 
characteristics for eligible participants will be compared according to successful 
enrollment versus not using two-sample tests for continuous and categorical data (e.g., t-
test, Wilcoxon rank sum test, chi-square test). Characteristics will include demographic 
features, clinical/cancer features, and optional QOL responses. 
EORTC QLQ-C30 subscale and overall scores will be used to describe participant 
symptom and health-related quality of life burden. SNSCS-SF34 scores will be used to 
categorize participants based on the degree to which their needs are met. Baseline EORTC 
QLQ-C30 and SCNS-SF34 scores will also be compared according to successful 
enrollment versus not using t-test or Wilcoxon rank sum tests depending on distribution of 
scores. These data may describe enrollment barriers previously unknown. For 
example, comorbidity burden, prior cancer treatment history, or self-reported quality of 
life at initial cancer presentation may be risk factors for elective participation. These 
analyses will provide preliminary data to inform evidence-based interventions aimed at 
increasing clinical trials participation among PWH at domestic AMC sites. To address 
minority and underserved populations, additional analyses will examine the interaction 
with race, ethnicity, socioeconomic status, and health insurance status to compare 
participant characteristics according to groups defined by enrollment status and these 
variables. Similarly, interactions with age, cancer type, treatment, and time since diagnosis 
will be investigated. Finally, these analyses will inform a multivariable logistic model that 
predicts successful trial outcome that includes dependent variables for participant 
characteristics; interactions with indicators of minority, socioeconomic status, and health 
insurance will be investigated in this model as well as with age, cancer type, treatment and 
time since diagnosis. 
10.4 
Exploratory Endpoints 
Exploratory endpoints for this study include: 
• To standardize and expand the quantity and quality of sociodemographic (e.g., 
racial/ethnic distribution, SES), HIV-related health [e.g., Antiretroviral Therapy 
(ART) medications, 
co-morbidities], 
and 
cancer 
diagnostic 
and 
treatment 
characteristics collected for PWH receiving care at domestic AMC sites. 

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• To describe cancer patient health-related QOL for PWH at domestic AMC sites using 
EORTC QLQ-C30 and SCNS-SF34. 
Exploratory endpoints will be analyzed as described below: 
1. The distribution of participant characteristics from Table 2-A will be summarized. 
2. The frequency of planned cancer treatment regimens successfully initiated will be 
summarized. 
3. PRO assessment scores from the EORTC QLQ-C30 and SCNS-SF34 will be 
summarized, both overall and at the ~12-week follow-up, according to participant 
characteristics and cancer groups. Overall change in PRO measures will be compared 
with paired tests and change according to groups will be compared using t-tests, 
ANOVA, or nonparametric tests. In an exploratory manner, PRO scores for PWH who 
are in remission will be analyzed separately to understand longer-term QOL issues that 
may inform future POSEC-led survivorship efforts. 
10.5 
Data and Safety Monitoring Board Review 
Per the AMC’s Data and Safety Monitoring Plan (DSMP; see Appendix III), DSMB 
reviews are only required for phase III randomized trials by NCI policy. This study will be 
monitored for safety and trial progress according to the procedures outlined in the DSMP 
only. 
 
 

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11.0 
ROLE OF DATA MANAGEMENT AND DATA REPORTING 
11.1 
Study Oversight 
This protocol is monitored at several levels, as described in this section. The Protocol 
Principal Investigator is responsible for monitoring the conduct and progress of the clinical 
trial, including the on-going review of accrual and patient-specific clinical and laboratory 
data. The Protocol Principal Investigator and statistician have access to the data at all times 
through the CTMS web-based reporting portal. 
All Study Investigators at participating sites who register/enroll participants on a given 
protocol are responsible for timely submission of data via Medidata Rave. This includes 
timely review of data collected on the electronic CRFs submitted via Medidata Rave. 
Permission to view and download this protocol and its supporting documents is restricted 
and is based on person and site roster assignment housed in the CTSU Regulatory Support 
System (RSS). 
This study is supported by the NCI Cancer Trials Support Unit (CTSU). 
All studies are also reviewed in accordance with the enrolling institution’s data safety 
monitoring plan. 
11.2 
CRF Instructions 
Access to the internet data entry system for this study, iMedidata Rave, and instructions 
for recording of study data on eCRFs will be provided by the AMC ODMC at 
www.AIDSCancer.org. Participating institutions are responsible for submitting data and/or 
data forms via iMedidata Rave in accordance with the AMC Data Entry Guide and specific 
form instructions, within the timelines specified by the AMC’s Standards of Procedure for 
Site Performance Measures. 
11.3 
Data Quality 
It is the responsibility of the AMC ODMC to assure the quality of data for the study (See 
Appendix III, AMC Data and Safety Monitoring Plan). This role extends from protocol 
development to generation of the final study database. 
11.4 
Data Reporting 
Medidata Rave is a clinical data management system being used for data collection for this 
trial/study. Access to the trial in Rave is controlled through the CTEP-IAM system and 
role assignments. To access Rave via iMedidata: 
• Site staff will need to be registered with CTEP and have a valid and active CTEP-IAM 
account, and 
• Assigned one of the following Rave roles on the relevant Lead Protocol Organization 
(LPO) or Participating Organization roster at the enrolling site: Rave CRA, Rave Read 
Only, Rave CRA (LabAdmin), Rave SLA, or Rave Investigator. Refer to 
https://ctep.cancer.gov/investigatorResources/default.htm for registration types and 
documentation required. 
o To hold Rave CRA or Rave CRA (Lab Admin) role, site staff must hold a minimum 
of an AP registration type, 

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o To hold Rave Investigator role, the individual must be registered as an NPIVR or 
IVR, and 
o To hold Rave Read Only role, site staff must hold an Associates (A) registration 
type. 
If the study has a DTL, individuals requiring write access to Rave must also be assigned 
the appropriate Rave tasks on the AMC DTL. 
Upon initial site registration approval for the study in Regulatory Support System (RSS), 
all persons with Rave roles assigned on the appropriate roster will be sent a study invitation 
e-mail from iMedidata. To accept the invitation, site staff must log in to the Select Login 
(https://login.imedidata.com/selectlogin) using their CTEP-IAM username and password 
and click on the accept link in the upper right-corner of the iMedidata page. Site staff will 
not be able to access the study in Rave until all required Medidata and study specific 
trainings are completed. Trainings will be in the form of electronic learnings (eLearnings) 
and can be accessed by clicking on the link in the upper right pane of the iMedidata screen. 
If an eLearning is required and has not yet been taken, the link to the eLearning will appear 
under the study name in iMedidata instead of the Rave EDC link; once the successful 
completion of the eLearning has been recorded, access to the study in Rave will be granted, 
and a Rave EDC link will display under the study name. 
Site staff that have not previously activated their iMedidata/Rave account at the time of 
initial site registration approval for the study in RSS will also receive a separate invitation 
from iMedidata to activate their account. Account activation instructions are located on the 
CTSU website in the Rave section under the Rave resource materials (Medidata Account 
Activation and Study Invitation Acceptance). Additional information on iMedidata/Rave 
is available on the CTSU members’ website in the Data Management > Rave section at 
www.ctsu.org/RAVE/ or by contacting the CTSU Help Desk at 1-888-823-5923 or by e-
mail at ctsucontact@westat.com. 
11.5 
Data Monitoring 
Required submission of patient demographic data for this study will be submitted 
automatically via OPEN. 

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12.0 
ETHICAL AND REGULATORY CONSIDERATIONS 
12.1 
IRB Approval and Informed Consent 
Records of all study review and approval documents must be kept on file by the 
Investigator and are subject to inspection during or after completion of the study. The IRB 
should receive notification of completion of the study and final report within 3 months of 
study completion and termination. The Investigator will maintain an accurate and complete 
record of all submissions made to the IRB, including a list of all reports and documents 
submitted. 
To determine the types of cancer cases that present to the clinical sites, it is requested that 
all cancer patients presenting at these sites have a minimum set of de-identified data 
collected. This will be performed prior to formal consent and meets criteria for minimal 
risk data collection. Data collected on cancer patients presenting to the clinical site will 
include age, sex at birth, race/ethnicity, and type of cancer. Data collected during screening 
will be maintained separately from data on enrolled cases. No other data will be collected 
on patients who do not consent to participate in AMC-115.  
Written informed consent will be obtained from the participant to collect identifiable data. 
The nature, significance and risks associated with the study must be explained to the 
participant. The informed consent will describe the purpose of the study, the procedures to 
be followed, the risks and benefits of participation, all risks of the investigational agent(s) 
and/or study participation as listed in the model informed consent form, and all other 
elements of informed consent as required by regulation. A copy of the consent form will 
be given to the participant to keep. 
In addition, any institution(s) conducting research according to the guidelines of this 
protocol is required to adhere to local and national laws and regulations governing the 
confidentiality and disclosure of health information. 
12.2 
Changes to the Protocol 
Any change or addition to this protocol requires a written protocol amendment that must 
be approved by CTEP and the Investigator before implementation. All amendments require 
approval by the CIRB. 
12.3 
Women and Minorities 
This study is being conducted by the NCI-sponsored AMC. As part of their contractual 
obligations, each participating site within the AMC and the AMC as a whole is required to 
assure that the participation of women and minority participants reflects the percentage 
representation of these populations in their geographic region and, for the AMC, PWH in 
the United States as a whole. As such, it is expected that the representation of participants 
on this trial will reflect the constitution of the respective populations see Table 12-A for 
accrual targets. 
 
 

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Table 12-A: Accrual targets 
DOMESTIC PLANNED SCREENING ENROLLMENT REPORT 
Racial 
Categories 
Ethnic Categories 
Total 
Not Hispanic or Latino 
Hispanic or Latino 
Female 
Male 
Female 
Male 
American 
Indian/ 
Alaska 
Native 
1 
3 
10 
23 
37 
Asian 
3 
10 
0 
0 
13 
Native 
Hawaiian or 
Other 
Pacific 
Islander 
1 
2 
0 
0 
3 
Black or 
African 
American 
98 
230 
10 
23 
361 
White 
38 
88 
30 
70 
226 
More Than 
One Race 
10 
20 
15 
35 
80 
Total 
151 
353 
65 
151 
720 
 

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13.0 
REFERENCES 
1. Shiels, M.S., et al., Projected Cancer Incidence Rates and Burden of Incident Cancer Cases 
in HIV-Infected Adults in the United States Through 2030. Ann Intern Med, 2018. 
168(12): p. 866-873. 
2. St Germain, D.C. and W. McCaskill-Stevens, Use of a clinical trial screening tool to 
enhance patient accrual. Cancer, 2021. 127(10): p. 1630-1637. 
3. Burkhalter, J.E., et al., Participant characteristics and clinical trial decision-making factors 
in AIDS malignancy consortium treatment trials for HIV-infected persons with cancer 
(AMC #S006). HIV Clin Trials, 2018. 19(6): p. 235-241. 
4. Hernández-Ramírez, R.U., et al., Cancer risk in HIV-infected people in the USA from 1996 to 
2012: a population-based, registry-linkage study. Lancet HIV, 2017. 4(11): p. e495-e504. 
 

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APPENDIX I: SCHEDULE OF EVALUATIONS 
The screening and enrollment evaluations below applies to all participants on study, while the 
follow-up evaluations at Week 12 only apply to participants who are planning to initiate therapy 
or currently under treatment. 
 
Screening 
Enrollment1 
Week 12 Follow-up (± 2 
weeks) 2* 
Informed consent 
X 
 
 
De-identified Demographics 
X 
 
 
Participant Characteristics 
 
X 
 
Sociodemographic 
 
X 
 
Health Behaviors 
 
X 
 
Comorbid Conditions 
 
X 
 
HIV Care 
 
X 
 
Status of Cancer Diagnosis  
 
X 
 
Cancer history 
 
X 
 
Cancer Treatment Plan 
(Prior and/or current) 
 
X 
X 
EORTC QLQ-C303  
 
X 
X 
SCNS-SF343 
 
X 
X 
Performance status 
 
X 
X 
 
 
* Participants in whom no further treatment is planned after enrollment do not require the 
Week 12 follow-up 
1Please see Section 8.2 for specific records to be collected. 
2Please see Section 8.3 for specific records to be collected. 
3Optional 
 
 
 

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APPENDIX II: PERFORMANCE STATUS SCALES 
Karnofsky Performance Scale 
ECOG Performance Status Scale 
Percent 
Description 
Grade 
Description 
100 
Normal, no complaints, no evidence of 
disease. 
0 
Normal activity. Fully active, able to carry 
on all pre-disease performance without 
restriction. 
90 
Able to carry on normal activity; minor 
signs or symptoms of disease. 
80 
Normal activity with effort; some signs or 
symptoms of disease. 
1 
Symptoms, but ambulatory. Restricted in 
physically strenuous activity, but 
ambulatory and able to carry out work of a 
light or sedentary nature (e.g., light 
housework, office work). 
70 
Cares for self, unable to carry on normal 
activity or to do active work. 
60 
Requires occasional assistance but is able 
to care for most of his/her needs. 
2 
In bed <50% of the time. Ambulatory and 
capable of all self-care, but unable to carry 
out any work activities. Up and about more 
than 50% of waking hours. 
50 
Requires considerable assistance and 
frequent medical care. 
40 
Disabled, requires special care and 
assistance. 
3 
In bed >50% of the time. Capable of only 
limited self-care, confined to bed or chair 
more than 50% of waking hours. 
30 
Severely disabled, hospitalization 
indicated. Death not imminent. 
20 
Very sick, hospitalization indicated. 
Death not imminent. 
4 
100% bedridden. Completely disabled. 
Cannot carry on any self-care. Totally 
confined to bed or chair. 
10 
Moribund, fatal processes progressing 
rapidly. 
0 
Dead. 
5 
Dead. 
 
 

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APPENDIX III: AMC DATA AND SAFETY MONITORING PLAN 
(Version 9.0  October 6, 2020) 
 
Introduction 
The AIDS Malignancy Consortium (AMC) Data and Safety Monitoring Plan (DSMP) outlines the 
measures employed by the group to monitor the safety of participants and ensure the data validity 
and integrity for all clinical trials it conducts. This includes methods to: 1) monitor the progress of 
trials and the safety of participants; 2) comply with regulatory requirements for adverse event (AE) 
reporting; 3) processes for trial termination or temporary suspension and major modifications; and 
4) plans for ensuring data accuracy and protocol compliance. As the AMC conducts protocols of 
varying research phase, region of conduct (which may include trials conducted in the U.S., 
international sites, or both), IND sponsor (AMC investigator, CTEP, or industry-sponsored) and 
clinical data entry system use, this plan addresses broad processes applying to the range of trial 
designs and requirements. Refer to the individual AMC protocol to identify the applicable study 
characteristics for the relevant requirements described in this plan. 
Monitoring the Progress of Trials and the Safety of Participants 
Routine and expedited AE reporting 
All AMC protocols that collect safety data adhere to the National Cancer Institute (NCI), Cancer 
Therapy 
Evaluation 
Program 
(CTEP) 
Guidelines: 
Adverse 
Event 
Reporting 
Requirements (https://ctep.cancer.gov/protocolDevelopment/adverse_effects.htm), as applicable 
to the clinical protocol. AEs are to be recorded in the source documents, assessed by a clinical 
investigator for the AE reporting criteria, and promptly reported in the clinical data entry system 
as required by each protocol. For AMC trials conducted under a CTEP IND and AMC trials 
conducted within the U.S., all AEs that meet the NCI’s expedited reporting requirements are 
reported to the NCI via the CTEP Adverse Event Reporting System (CTEP-AERS) web 
application, either directly or through integration with Medidata Rave where this system is 
employed for AMC protocols. Use of this system ensures notification to the protocol chair and 
Investigational Drug Branch (IDB) at CTEP, as required for trials conducted under a CTEP IND, 
and a uniform expedited reporting and safety review process for AMC domestic trials. The system 
may also be programmed to include sponsor notification as required for trials with industry 
support. Alternate process for expedited AE reporting to the AMC protocol chairs and AMC 
Operations and Data Management Center (ODMC) within the clinical data entry system 
(AdvantageEDC or Advantage eClinical only) may be defined in the protocol for select trials 
(international studies and The ANCHOR Study). 
All serious adverse events (SAEs) received by the AMC ODMC will be reviewed by the 
AMC medical monitor at the AMC ODMC for consideration of individual participant safety, safe 
trial conduct, data reporting quality for AE term selection, and appropriate application of the 
regulatory criteria for seriousness, expectedness, and relatedness to the investigational therapy. If 
alternate procedures are followed for SAE review, the process for adequate medical monitoring 
will be defined in the AMC protocol and the Transfer of Regulatory Obligations (TORO) with the 
sponsor. AMC medical monitor review includes review of the CTEP-AERS report before CTEP 
submission for IDB review (if applicable), or review of the SAE report in the data entry system 
for trials not using CTEP-AERS for expedited reporting. The IND sponsor or its designee will 

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issue the determination as to whether the AE requires IND safety reporting to FDA as a serious 
and unexpected suspected adverse drug reaction (SUSAR). For protocols not conducted under an 
IND, in the event of disagreement between the reporting physician and the AMC medical monitor 
regarding the relationship of the AE to the investigational agent(s) (i.e., determination of whether 
the attribution is unrelated or unlikely, or possible, probable, or definite), the AMC medical 
monitor will provide the final determination of the relationship. IND safety reporting to FDA is 
performed by CTEP for trials conducted under a CTEP IND; IND safety reporting is performed 
by the sponsor or sponsor’s designee (AMC ODMC or other party defined in the study agreement 
or TORO) for IND studies sponsored by AMC investigators or industry sponsors. 
Expedited reporting to the Institutional Review Board (IRB) 
The requirements for IRB review will be identified in the protocol section on ethical and regulatory 
obligations. All AMC trials initiated before September 1, 2020 and all international sites for all 
AMC studies are subject to local IRB review; only U.S. sites are subject to the NCI requirement 
to use a single IRB for protocols initiated on or after September 1, 2020. For trials subject to local 
IRB review, the site principal investigator is responsible for ensuring that expedited AE reports for 
its trial participants and any unanticipated problems that affect the local institution only are 
submitted to the local IRB of the reporting institution, per the local IRB’s requirements for such 
reporting. For studies reviewed by the single IRB, the protocol chair will render a determination 
as to whether a SAE or other problem constitutes a trial-wide unanticipated problem that requires 
reporting to that RB, in accordance with its standards of procedure. 
To comply with investigator notification requirements for IND studies under 21 CFR 312.32 and 
312.55, IND safety reports from all trials the AMC conducts and reports from external sponsors 
investigating the same agents are made available to all investigators upon receipt from the sponsor 
or its designee, either via the password-protected section of the AMC Operations web site (AMC 
trials subject to local IRB review only) or the CTSU website (U.S. trials subject to single IRB 
review/CTEP IND agents). The site clinical investigator responsible for the applicable AMC 
protocol(s) is responsible for reviewing any IND safety reports received and documenting 
submission to the IRB of record (if required by local policy) within the timeline defined 
by the Clinical Trials Monitoring Branch (CTMB) audit guidelines. 
Procedures for monitoring trial progress and pharmacovigilance 
For trials using AdvantageEDC or Advantage eClinical for clinical data entry, the AMC ODMC 
provides on demand tabular listings of all reported AEs and SAEs on a participant level to 
the protocol chair and co-chair(s) for review via the password-protected section of the 
AMC Operations web site, www.AIDScancer.org. For trials using OPEN and Medidata Rave for 
clinical data collection, data listing will be made available using that system. Summary reports of 
AEs by frequency and relationship to the investigational agent(s) are provided to all AMC 
investigators and their staff It is the responsibility of each site to provide trial-specific AE 
listings to their respective IRB, if required by its policies. For blinded studies, the AE and SAE 
listings are reviewed and tabulated without treatment assignment. 
Accrual summaries for each AMC trial are updated nightly on the password-protected section of 
the AMC web site. The progress of each AMC trial is reviewed regularly by the protocol chair and 
also by 
the 
appropriate Scientific Working 
Group (SWG) during 
scheduled 
conference 
calls (monthly SWG calls and as required, protocol-specific monitoring conference 

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calls). Summary accrual, summary AE, and individual SAE reports are provided to SWG 
leadership and protocol chairs to monitor participant safety during these monthly calls. 
The AMC medical monitor reviews listings of all reported AEs on a quarterly basis for assuring 
compliance with the protocol requirements for AE reporting and the identification of any safety 
concerns (individual AE or increased frequency/severity of expected AEs) for the agents under 
investigation. Findings from these reviews are communicated to the protocol chairs and all 
AMC investigators, and posted to the AMC Operations web site. 
Data and Safety Monitoring Board Review (DSMB) review 
The AMC has formed an independent Data and Safety Monitoring Board (DSMB) for AMC trials 
and for the ANCHOR Study. As required by NCI policy, the AMC requires DSMB review for 
all phase III randomized trials. All other clinical trials that the AMC initiates will be reviewed by 
the AMC ODMC and AMC Statistical Center during protocol development to issue a 
recommendation as to whether the study requires DSMB oversight, which will require the 
approval of the AMC Executive Committee. This determination will be based on the phase of the 
study, experimental design, risk posed by the investigational approach, extent of data available on 
the safety of an investigational agent, risk posed by the natural course of the health condition under 
research, and the categories of vulnerable populations involved. The involvement of a DSMB in 
reviewing an AMC protocol will be identified in each clinical protocol as approved by CTEP and, 
as applicable, required by the IRB of record. 
Regarding the composition of the AMC DSMB, voting members usually include physicians, 
statisticians, an ethicist, and a patient advocate. All voting members have no other affiliation to 
the AMC and are appointed by the AMC Executive Committee with the approval of the OHAM 
Director. Nonvoting members are the AMC group statistician, the protocol statistician, an 
AMC ODMC staff member, two representatives (normally a clinician or statistician) from CTEP, 
and the grant program directors from the NCI Office of HIV and AIDS Malignancy (OHAM). 
The DSMB reviews all applicable AMC studies in accordance with the National Cancer Institute’s 
Policy for Data and Safety Monitoring. Confidential reports of all trials under review are prepared 
by the AMC group statistician with support from the AMC ODMC. A written report containing 
the current status of each trial monitored, and when appropriate, any toxicity and outcome 
data, are sent to DSMB members by the AMC ODMC within the timelines specified by the 
DSMB charter. This report addresses specific toxicity issues and any other concerns about the 
conduct of the trial, as defined by the protocol plan for DSMB review. The report may 
contain information for the DSMB to render determinations for participant safety, early trial 
termination, results reporting, or continuing accrual or follow-up. 
The results of each DSMB meeting are summarized in a formal report sent by the DSMB chair to 
the AMC group chair and AMC ODMC. The DSMB report contains recommendations on whether 
to close each study reviewed, whether to report the results, and whether to continue accrual or 
follow-up. A primary recommendation (e.g., continue with no change; recommended or required 
modification; stop) must be included in the document. The group chair or designee is then 
responsible for notifying the protocol chair and relevant SWG chair before the recommendations 
of the DSMB are carried out. In the unlikely event that the protocol chair does not concur with the 
DSMB, then the OHAM program directors and the NCI division director or designee must be 
informed of the reason for the disagreement. The protocol chair, relevant SWG chair, group chair, 
DSMB chair, and NCI division director or designee will be responsible for reaching a mutually 

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acceptable decision about the study. CTEP approval of a protocol amendment will be required 
prior to any implementation of a change to the study. 
Following a DSMB meeting, the DSMB’s recommendations are provided to all AMC 
investigators and staff. It is each site principal investigator’s responsibility for conveying this 
information to its local IRB as relevant for its protocol participation. For trials reviewed by a single 
IRB, the AMC ODMC will support notification to the IRB as required per its procedures. 
Cohort trial reviews not subject to DSMB review 
For phase I dose escalation trials, dose escalation (or dose de-escalation) is based on the rules in 
the protocol and the protocol chair, AMC medical monitor, and protocol statistician determine 
whether these criteria have been met based on a review of all safety data for the protocol-defined 
evaluation period. If applicable for phase II trials, stopping the trial for toxicity or efficacy, or 
suspending enrollment pending observation of responses in a multi-stage phase II trial, is based on 
meeting criteria stated in the protocol, and the protocol chair, AMC medical monitor, 
and protocol statistician determine whether these criteria have been met. 
Plans for Assuring Compliance with Requirements Regarding AE Reporting 
The protocol chair, AMC group chair, and the AMC ODMC share responsibility in assuring that 
participating investigators comply with applicable regulatory and protocol requirements 
for AE reporting. The AMC site principal investigator certifies compliance with NCI and FDA 
requirements for trial conduct by signing the site subaward agreement for the grant and the AMC 
Adherence Statement for site membership; clinical investigators also certify compliance in 
completing the protocol signature page for each protocol active at the site, and Form FDA-1572 
for CTEP investigator registration, and also for AMC IND studies sponsored by AMC 
investigators or industry sponsors. Protocol compliance with AE identification, assessment 
and reporting requirements is assessed by the AMC ODMC using several methods: 1) 
programmed system checks and messages to instruct the site to complete routine and/or expedited 
reporting when certain criteria are reported in the clinical data entry system; 2) programmed data 
reports provided to the protocol chairs that identify reports requiring expedited AE reporting; 3) 
remote review of data entry or data reports to ensure compliance with protocol and NCI AE 
reporting requirements; 4) AMC medical monitor review described in the section above; and, 
5) routine site audits by reviewing the site’s source documentation. 
The clinical data entry systems used for AMC studies include the Oncology Patient Enrollment 
Network, OPEN for enrollment, and Medidata Rave for clinical data entry for enrolled 
participants; trials activated before September 1, 2020 or that involve only AMC international sites 
may be reported in AdvantageEDC/Advantage eClinical, a web-based data entry and enrollment 
system. These data entry systems are programmed to notify the site investigator, protocol chair, 
AMC medical monitor, and AMC ODMC via email in the event that a site reports an AE that 
meets expedited reporting criteria to NCI and/or FDA. Additional reporting conditions may be 
programmed depending on the sponsor reporting requirements of a given protocol (e.g., adverse 
events of special interest [AESI]). If the site does not follow with an expedited report, the AMC 
ODMC contacts sites to request compliance with reporting requirements. Additionally, the 
protocol chair, AMC ODMC, and the AMC medical monitor review reported AEs on a routine 
basis to identify AEs reported by sites that require expedited reporting. The protocol chair, AMC 
SWG chairs, AMC group chair, and IND sponsors have general oversight for assuring that routine 
and expedited adverse reporting requirements are met by the responsible parties. 

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RESTRICTED 
For studies monitored by CTEP using the Data Mapping Utility (DMU), cumulative protocol- and 
patient-specific data will be submitted weekly to CTEP electronically via the DMU. For 
trials monitored by the NCI’s Clinical Data Update System (CDUS), AE information is 
transmitted electronically to NCI on a quarterly basis. For trials monitored by NCI’s Clinical Trials 
Monitoring Service (CTMS), AE information is transmitted electronically to NCI every two 
weeks. 
Plans for Assuring that any Action Resulting in a Temporary or Permanent Suspension of 
an NCI-Funded Clinical Trial is Reported to the NCI Grant Program Director Responsible 
for the Grant 
In the event that temporary or permanent suspension of a trial, or major modification to the 
protocol is under consideration, the protocol chair will convene the AMC ODMC, AMC Statistical 
Center, and SWG chair by conference call to discuss the options. Suspension actions will also be 
reviewed by the AMC Executive Committee for program oversight and direct communication of 
the action with the OHAM program directors. For phase III trials, closure decisions are typically 
rendered by the AMC DSMB; if the trial in question is under AMC DSMB oversight but rendered 
by the AMC investigators, the AMC DSMB will be notified of the suspension and the reason. For 
phase I and II trials, the protocol chair also has the option of asking the DSMB to review the study. 
The AMC ODMC will inform the CTEP Protocol Information Office (PIO), with copy to OHAM 
Directors, when studies are temporarily or permanently closed. In the event of major trial 
modification, CTEP must approve all protocol amendments prior to distributing to the AMC sites. 
Plans for Assuring Data Accuracy and Protocol Compliance 
All study data for AMC clinical trials are entered directly by AMC clinical site staff into the 
applicable clinical data entry system for the trial. During data entry, the system performs validation 
checks on many fields and performs consistency checks between select fields. Range checks are 
placed on each field to eliminate entry of out-of-range values. Edit check programs are run on the 
database on a set schedule to identify and resolve inconsistencies between forms or data collected 
at different points in time. Submitted data entry forms are reviewed for compliance with the 
protocol and data entry instructions according to the AMC ODMC’s standards for data quality 
processes. AMC 
ODMC 
staff 
routinely 
interacts 
with 
site 
staff 
to 
resolve 
any 
data submission problems. 
In accordance with NCI guidelines, the AMC ODMC conducts audits at the AMC sites to evaluate 
compliance with regulatory issues, and to review data for specific cases by checking source 
documents. These reports are sent to the site principal investigator and to the NCI. In the event 
that major violations are identified, sites are asked to provide a written corrective and preventative 
action plan to correct deficiencies. If needed, a repeat site audit is conducted. In the event that a 
site does not correct deficiencies in a pre-determined time frame, the AMC Executive Committee 
has the option to implement remedial action(s) for the site. Possible actions include, but are not 
limited to, suspending enrollment of new participants to AMC trials until deficiencies are 
corrected; recommending a decrease in funding to the site; and requiring specific training for site 
investigators or staff members.