ASCO Survey on Coronavirus Disease 2019 (COVID-19) in Oncology (ASCO) Registry
Conditions: Neoplasms, Coronavirus
Sponsor: American Society of Clinical Oncology

 
ASCO Survey on COVID-19 in Oncology (ASCO) Registry 
Study Schema – 10.6.2020 
 
Rationale 
The COVID-19 Pandemic presents a unique opportunity to capture information on how a disease 
outbreak affects delivery of high-quality cancer care. ASCO is providing the means for the oncology 
community to rapidly submit data that will inform both current cancer care and provide information to 
help guide decision-making for future disease outbreaks. While other entities have launched COVID-19 
cancer registries, ASCO has extensive relationships with the entire cancer care community, particularly 
private practices that may be caring for the majority of cancer patients with COVID-19. ASCO’s registry 
collects information about patients undergoing treatment for cancer and with confirmed COVID-19 
infection based on a positive test. Unlike other registries, ASCO’s registry collects follow-up information 
on both COVID-19 disease and cancer outcomes at 30-day intervals for the first 90 days and 90-day 
intervals thereafter up to one year after COVID-19 diagnosis. 
 
Project Objectives:  
• 
Capture and describe cancer and COVID-19 status at COVID-19 diagnosis, and cancer and COVID-
19 outcomes of patients with cancer and COVID-19 from participating cancer 
practices/institutions. Data collected will include treatment approaches, cancer status, changes 
to cancer treatment plans in patients with confirmed SARS-CoV-2 infection, status of COVID-19 
infection (e.g., severity of symptoms, need for ventilator, hospitalization, etc.) and cancer (e.g., 
cancer progression, treatment-related changes/modifications, etc.).  
 
Project Deliverables: 
• 
Periodic Reports on Patient Population, Estimates of Disease Severity, Treatment Modifications, 
and Clinical Outcomes Among Patients – for participating sites and publicly accessible on ASCO 
websites for the oncology community  
• 
Manuscript(s) for Submission to Peer-Reviewed Journals  
 
Research Objectives:  
Objective 1: Describe the distribution of symptoms and severity of COVID-19 among patients with 
cancer (on active treatment or on adjuvant treatment within 12 months after surgical resection) who 
have confirmed infection of SARS-CoV-2  
• 
Objective 1.1: Describe distribution of symptoms and severity of COVID-19 stratified 
according to demographic characteristics, including age, cancer type, cancer extent, race, 
ethnicity, geography, type of therapy received, smoking status, comorbidities, etc. 
• 
Objective 1.2: Identify characteristics independently associated with severity of COVID-19 in 
cancer patients. 
 
Objective 2: Examine SARS-CoV-2 viral infection outcomes (ongoing, recovery, hospitalized, not in 
ICU; hospitalized in ICU; placed on ventilator; death due to COVID-19 disease complications) and 

cancer outcomes (stable, response to treatment, progression, delayed treatment, treatment 
discontinued, and death) 
• 
Objective 2.1: Stratify patients with SARS-CoV-2 viral infection according to characteristics 
described in Objective 1.1 to examine whether any of the characteristics are independently 
associated with COVID-19 and/or cancer outcomes 
• 
Objective 2.2: Examine the relationship between SARS-CoV-2 viral infection outcomes and 
cancer outcomes and whether SARS-CoV-2 viral infection outcomes are independently 
associated with cancer outcomes 
 
Objective 3:  To describe effects of the COVID-19 pandemic on cancer practices in the U.S., including 
changes in staffing and resource availability, prioritizations for patient care, and modification of 
interactions between care providers and patients (including use of telemedicine) 
 
Eligibility Criteria:  
The registry will collect data about patients with a cancer diagnosis who have a confirmed SARS-CoV-2 
infection and are being treated at participating cancer practices/institutions within the United States. 
 Patients in one of the four categories are eligible:   
1. Patients with a new cancer diagnosis and in the process of cancer staging and/or receipt of 
initial cancer therapy 
2. Patients with clinically evident cancer receiving anti-cancer treatment,  
3. Patients who are disease free, but receiving any type of adjuvant therapy within 1 year 
following surgical resection (including hormonal treatments), and  
4. Patients with clinically evident cancer receiving supportive care only. 
 
Statistical Considerations and Reporting 
ASCO’s Center for Research and Analytics (CENTRA) will periodically create reports to share with 
participating practices and the general cancer community, and submit manuscripts for publication. 
Reports will summarize overall and stratified by patient characteristics, such as disease sites and stage, 
age and comorbidities. Reports or publications will also include cancer treatment delay and 
discontinuation of cancer treatments including surgery, radiation and drug-based therapies, due to the 
patient’s COVID-19 disease and to other factors, with stratification by other variables as described 
above. Changes in practices’ patterns of care, staffing, resources, and interactions with patients will also 
be evaluated and summarized.  
 
As there is no hypothesis testing planned, there is no required sample size and providing repeated 
reports, with cumulative information, will not affect validity of results. Confidence intervals will be 
provided where appropriate to demonstrate precision of estimates.   
 
IRB Review 
ASCO received approval from the Western Institutional Review Board (WIRB): 
“We determined this study is exempt from IRB review because it does not meet the definition of 
human subject as defined in 45 CFR 46.102. Specifically this study will [sic] deidentified data in the 
form of limited data sets from the participating clinics and institutions and you will enter into Data 
Use Agreements, and you will not otherwise interact with the patients.” 

The WIRB letter is available on the ASCO Registry website. ASCO encourages practices to rely on the 
WIRB review. If local IRB approval is necessary, the review must be completed before the practice can 
execute the data use agreement (DUA) with ASCO. 
 
Practice Expectations (Refer also to study calendar in Appendix.) 
• 
Review study schema, data collection elements, and WIRB determination. 
• 
Complete practice contact information (link available at the ASCO Registry website) and 
download the DUA. In the interest of prompt data reporting, ASCO will only entertain DUA 
revisions related to the local site contact information.  
• 
Contact CENTRA@ASCO.org to express interest in participation and execute DUA with ASCO. 
• 
Access web address provided by ASCO for data entry and select practice name from the drop-
down list of practices that have executed a DUA. 
• 
Complete initial and follow-up data entry forms. Follow-up data includes information on COVID-
19 and cancer treatment and outcomes. Ideally, data entry will be done routinely. ASCO 
requests case updates at 30-, 60-, 90-, 180-, 270-, and 360-day intervals, unless a patient has left 
the practice or died. Where necessary, practices should attempt to obtain information from 
inpatient hospitalizations. 
o Data includes:  
 
Limited patient identifiable data, including home zip code, practice zip code, and 
date of birth 
 
Demographics (e.g., gender, race, ethnicity, type of cancer, and comorbidities)  
 
COVID-19 status (e.g.  symptoms, treatments, and outcomes) 
 
Cancer status (e.g., treatment plans, any changes to treatment plans, and 
response to treatments) 
o ASCO encourages practices to create a local standard operating procedure (SOP) to 
arrange systematic data entry. Retrospective data could be retrieved from the EHR using 
the new ICD-10-CM diagnosis code U07.1 (created by the Centers for Disease Control 
and Prevention (CDC) on March 18, 2020). Previous ICD-10-CM codes were 1) 
Coronavirus, as cause of disease classified elsewhere B97.29, 2) Coronavirus NEC B34.2, 
and 3) SARS-associated coronavirus J12.81. The coding system for laboratory and clinical 
test results (LOINC) has also established several codes for tests for the COVID-19 virus: 
SARS Coronavirus 2. 
o Practices may have to contact the hospital for information regarding an inpatient 
admission.  
• 
ASCO provides participating sites with a practice-based stipend in the first 30 days following 
contract execution and case-based stipends after the first 30-day update to help cover the costs 
of entering registry data.  
Participating practices are listed on the ASCO Registry webpage. Practices may withdraw from the 
registry at any time. 
 
Please contact CENTRA@ASCO.org for additional information or questions.  
 
The ASCO Registry is supported by Conquer Cancer’s COVID Impacts Cancer Fund. 
 
 

 
 
Appendix – Study Calendar and Timelines 
 
 
Study Calendar for Patients in ASCO Survey on COVID-19 in Oncology Registry 
 
This schedule is intended to ensure consistent reporting across practices. It is important for practices to 
follow the schedule as close as possible because deviations may impact the quality of data in the registry 
and accuracy of inferences. However, ASCO acknowledges that adjustments may need to be made for 
some practices.  
 
Phase 
Initial 
Entry 
Short term  
Follow-up 
Long-term  
Follow-up 
 
Initial 
at time of 
COVID-19 
diagnosis1 
1 month 
after 
COVID-19 
diagnosis 
2 months 
after 
COVID-19 
diagnosis 
 3 months 
after 
COVID-19 
diagnosis 
 6, 9 and 12 months 
after COVID-19 
diagnosis 
 
 
 
 
 
 
Initial Entry: At time of COVID-
19 diagnosis 
 
 
 
 
 
Initial Clinical and 
Demographic Information 
● 
 
 
 
 
COVID-19 Diagnosis 
Symptoms, and Treatment 
● 
 
 
 
 
Cancer Diagnosis, Status, and 
Treatment 
● 
 
 
 
 
Short Term Follow-up 
 
 
 
 
 
COVID-19 Status Update 
 
● 
● 
● 
 
Cancer Status Update 
 
● 
● 
● 
 
Long Term Follow-up 
 
 
 
 
 
COVID-19 Long-term Update 
 
 
 
 
● 
Cancer Long-term Update 
 
 
 
 
● 
1 If patient is deceased at the time of initial form submission or leaves practice prior to 30 days, a 
practice should complete a patient update form at any time and receive payment for the case in that 
month.

 
Page 5 of 5 
 
 
 
 
Registry Schedule for Participating Practices 
 
 
 
1Patient COVID-19 and cancer status updates should be entered every 30 days for first 90 days and 
every 90 days thereafter, for at least 12 months, closure of registry, or death/patient leaves 
practice (whichever occurs first). 
3Practice status updates may be requested periodically. 
Patient  
Cancer  
Status Updates1 
Research  
and Data Use 
Agreement 
Execution 
Baseline  
Practice  
Information 
Practice  
Contact 
Information 
Initial 
Patient 
Information 
Patient  
COVID-19  
Status Updates1 
Practice  
Status 
Updates 
Practice Enrollment 
Data Collection