ASCO Survey on COVID-19 in Oncology (ASCO) Registry

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.