Clinical trial NCT05510908: Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC
Official title: 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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HIV-Associated Malignant Neoplasm
HIV Infections
Cancer
AIDS Related Lymphoma
AIDS-related Kaposi Sarcoma
AIDS-Related Malignancy
Anal Cancer
HPV-Related Malignancy
Keywords: HIV-Related Cancer
AIDS
AIDS-related malignancy
anal cancer
lymphoma
kaposi sarcoma
cervical cancer
Lead sponsor: AIDS Malignancy Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-08-22
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: This study is being done to understand how many people with HIV (PWH) present for cancer care across the AIDS Malignancy Consortium in the United States and if there are reasons that some PWH choose to participate, or not in cancer clinical trials. Optional quality of life surveys will be used to learn more about how HIV and cancer and HIV and cancer treatment affect people.


Eligibility criteria: Inclusion Criteria:

* Participant can understand and is willing to sign a written informed consent document.
* 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 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.

* 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.
* Age ≥ 18 years.
* Participant presents to an AMC domestic clinical trial site for either clinical care or research.

Exclusion Criteria:

* Participants who do not fulfill the criteria as listed above are ineligible.

Primary outcomes:
measure: Number of cancers in people with HIV (PWH) who present for care at domestic AMC sites
timeFrame: Enrollment
Secondary outcomes:
measure: Proportion of participants eligible for AMC trials who are successfully enrolled
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Describe the sociodemographic, HIV-related, and cancer diagnostic and treatment characteristics of cancer patients with HIV receiving care at domestic AMC sites.
timeFrame: Baseline and 12 weeks
measure: Describe the health-related QOL of cancer patients with HIV at domestic AMC sites using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]
timeFrame: Baseline
measure: Describe the supportive care needs of cancer patients with HIV at domestic AMC sites using Supportive Care Needs Survey Short Form 34 [SCNS-SF34]
timeFrame: Baseline
measure: Change of Quality of Life at 12 Weeks From Baseline for cancer patients with HIV initiating therapy or currently under treatment using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]
timeFrame: Baseline and 12 weeks
measure: Change of needs from baseline for cancer patients with HIV initiating therapy or currently under treatment using Supportive Care Needs Short Survey Form 34 [SCNS-SF34]
timeFrame: Baseline and 12 weeks
measure: 3. State of planned cancer therapy for cancer patients with HIV initiating therapy or currently under treatment
timeFrame: 12 weeks
Locations:
city: La Jolla
country: United States
facility: Moores UCSD Cancer Center
state: California
city: District of columbia
country: United States
facility: George Washington University Cancer Center
state: District of Columbia
city: Miami
country: United States
facility: University of Miami Miller School of Medicine-Sylvester Cancer Center
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine - Cornell Clinical Trials Unit
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Abramson Cancer Center at Pennsylvania Hospital
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute - University of Utah
state: Utah
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
References: