Official Title
ASCO Survey on Coronavirus Disease 2019 (COVID-19) in Oncology (ASCO) Registry
Brief Summary

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

Detailed Description

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.

Active, not recruiting
Neoplasms
Coronavirus
Eligibility Criteria

Inclusion Criteria:

- COVID-19 positive diagnosis

- One of the following;

1. Patient has active cancer at the time of COVID-19 diagnosis OR

2. Patient has been cancer-free for less than 12 months AND receiving adjuvant
therapy at the time of COVID-19 diagnosis

Exclusion Criteria:

- COVID-19 suspected, but no positive test result

- Patient is a cancer-free not receiving any anti-cancer or adjuvant treatment

- Patient is receiving adjuvant therapy, but has been cancer-free for up to 12 months
at the time of COVID-19 diagnosis

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
United States
Locations

University of Alabama at Birmingham
Birmingham, Alabama, United States

Infirmary Cancer Care
Mobile, Alabama, United States

Anchorage Oncology Center
Anchorage, Alaska, United States

AIS Cancer Center
Bakersfield, California, United States

Long Beach Memorial Medical Center
Fountain Valley, California, United States

Orange Coast Medical Center
Fountain Valley, California, United States

Saddleback Memorial Medical Center
Fountain Valley, California, United States

Helen Diller Family Comprehensive Cancer Center, UCSF
San Francisco, California, United States

Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, United States

PIH Health
Whittier, California, United States

Hartford HealthCare Cancer Institute
Hartford, Connecticut, United States

Day Kimball Healthcare
Putnam, Connecticut, United States

Bayhealth Medical Center
Dover, Delaware, United States

Florida Precision Oncology, A Division of 21st Centry Oncology
Fort Myers, Florida, United States

Florida Cancer Specialists - Sarah Cannon Research Institute
Sarasota, Florida, United States

University of South Florida
Tampa, Florida, United States

Emory University Winship Cancer Institute
Atlanta, Georgia, United States

Augusta University
Augusta, Georgia, United States

Cancer Center of Middle Georgia, LLC
Dublin, Georgia, United States

Hawaii Cancer Care
Honolulu, Hawaii, United States

University of Chicago
Chicago, Illinois, United States

NorthShore University HealthSystem
Evanston, Illinois, United States

OSF Little Company of Mary Hospital
Evergreen Park, Illinois, United States

Joliet Oncology-Hematology Associates
Joliet, Illinois, United States

Edward-Elmhurst Healthcare
Naperville, Illinois, United States

Illinois Cancer Care
Peoria, Illinois, United States

Quincy Medical Group Cancer Institute
Quincy, Illinois, United States

Goshen Center for Cancer Care
Goshen, Indiana, United States

Michiana Hematology Oncology
Mishawaka, Indiana, United States

Midwest Oncology Associates - Sarah Cannon Research Institute
Overland Park, Kansas, United States

University of Kansas Medical Center
Westwood, Kansas, United States

Baptist Health Madisonville
Madisonville, Kentucky, United States

Greater Baltimore Medical Center
Baltimore, Maryland, United States

Saint Agnes Hospital Cancer Institute
Baltimore, Maryland, United States

Tufts Medical Center
Boston, Massachusetts, United States

Great Lakes Cancer Management Specialists
Grosse Pointe Woods, Michigan, United States

Mayo Clinic
Rochester, Minnesota, United States

Boone Hospital Center
Columbia, Missouri, United States

Mosaic Cancer Care
Saint Joseph, Missouri, United States

Nebraska Hematology Oncology
Lincoln, Nebraska, United States

Callahan Cancer Center
North Platte, Nebraska, United States

Nebraska Cancer Specialists
Omaha, Nebraska, United States

University of Nebraska Medical Center
Omaha, Nebraska, United States

Bayonne Medical Center
Bayonne, New Jersey, United States

CarePoint Health - Christ Hospital
Jersey City, New Jersey, United States

Penn Medicine, Princeton Health
Plainsboro, New Jersey, United States

Hematology Oncology Associates of Central New York
East Syracuse, New York, United States

Northwell Health Cancer Institute
Lake Success, New York, United States

Memorial Sloan Kettering Cancer Center
New York, New York, United States

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States

Levine Cancer Institute Atrium Health
Charlotte, North Carolina, United States

East Carolina University
Greenville, North Carolina, United States

Carteret Health Care
Morehead City, North Carolina, United States

CarolinaEast Medical Center
New Bern, North Carolina, United States

Regional Medical Oncology Center
Wilson, North Carolina, United States

Aultman Hospital
Canton, Ohio, United States

Cincinnati Children's Hospital
Cincinnati, Ohio, United States

Oncology Hematology Care
Cincinnati, Ohio, United States

University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States

TriCounty Hematology and Oncology
Massillon, Ohio, United States

Columbia Memorial Hospital
Astoria, Oregon, United States

Samaritan Health Services Corvallis
Corvallis, Oregon, United States

Penn Medicine, Lancaster General Health
Lancaster, Pennsylvania, United States

University of Pennsylvania
Philadelphia, Pennsylvania, United States

Thomas Jefferson University
Philadelphia, Pennsylvania, United States

Lexington Oncology
West Columbia, South Carolina, United States

Monument Health
Rapid City, South Dakota, United States

Kirkland Cancer Center
Jackson, Tennessee, United States

Baptist Clinical Research Institute
Memphis, Tennessee, United States

Tennessee Oncology
Nashville, Tennessee, United States

The START Center for Cancer Care
San Antonio, Texas, United States

University of Texas, Health Science Center
San Antonio, Texas, United States

Virginia Cancer Specialists
Fairfax, Virginia, United States

Augusta Health
Fishersville, Virginia, United States

Hematology Oncology Associates of Fredericksburg
Fredericksburg, Virginia, United States

Virginia Cancer Institute
Richmond, Virginia, United States

PeaceHealth
Vancouver, Washington, United States

American Society of Clinical Oncology
NCT Number
Keywords
cancer
MeSH Terms
Coronavirus Infections