Summary

The American Society of Clinical Oncology (ASCO) Survey on Coronavirus 2019 (COVID-19) in
Oncology Registry (ASCO Registry) aims to help the cancer community learn more about the
patterns of symptoms and severity of COVID-19 among patients with cancer, as well as how
COVID-19 is impacting the delivery of cancer care and patient outcomes. The ASCO Registry
collects both baseline and follow-up data on how the virus impacts cancer care and cancer
patient outcomes during the COVID-19 pandemic.

Objectives

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'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 includes treatment approaches, cancer status,
changes to cancer treatment plans in patients with confirmed severe acute respiratory
syndrome coronavirus 2 (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.).

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, priorities for patient
care, and modification of interactions between care providers and patients (including use
of telemedicine)

Eligibility Criteria:

The registry collects 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) reports via a data dashboard
(https://www.asco.org/covid-resources/asco-registry/data-dashboard) to the general cancer
community key characteristics of patients in the Registry. ASCO also submits abstracts
for presentation and manuscripts for publication. Reports summarize overall data 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 practice 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
reports also provided to other registries, with cumulative information, will not affect
validity of results. Confidence intervals will be provided where appropriate to
demonstrate precision of estimates.

Eligibility

1. COVID-19 positive diagnosis
2. One of the following;
3. Patient has active cancer at the time of COVID-19 diagnosis OR
4. Patient has been cancer-free for less than 12 months AND receiving adjuvant therapy at the time of COVID-19 diagnosis