NCT04659135

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

77 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

4.3 years

First QC Date

November 30, 2020

Last Update Submit

July 20, 2023

Conditions

Keywords

Cancer

Outcome Measures

Primary Outcomes (1)

  • Changes to Cancer Treatments

    Treatments: Yes vs. no response to changes in reported treatment administration for anti-cancer therapeutics

    24 months

Secondary Outcomes (7)

  • All-cause mortality at 30 days

    30 days

  • COVID-19 Symptoms

    24 months

  • COVID-19 Treatments

    24 months

  • Patient vital status

    24 months

  • Overall survival

    24 months

  • +2 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a cancer diagnosis who have a confirmed SARS-CoV-2 infection and are being treated for their cancer at participating cancer practices/institutions within the United States

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (77)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Infirmary Cancer Care

Mobile, Alabama, 36607, United States

Location

Anchorage Oncology Center

Anchorage, Alaska, 99508, United States

Location

AIS Cancer Center

Bakersfield, California, 93301, United States

Location

Long Beach Memorial Medical Center

Fountain Valley, California, 92708, United States

Location

Orange Coast Medical Center

Fountain Valley, California, 92708, United States

Location

Saddleback Memorial Medical Center

Fountain Valley, California, 92708, United States

Location

Helen Diller Family Comprehensive Cancer Center, UCSF

San Francisco, California, 94118, United States

Location

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, 96161, United States

Location

PIH Health

Whittier, California, 90602, United States

Location

Hartford HealthCare Cancer Institute

Hartford, Connecticut, 06102, United States

Location

Day Kimball Healthcare

Putnam, Connecticut, 06260, United States

Location

Bayhealth Medical Center

Dover, Delaware, 19901, United States

Location

Florida Precision Oncology, A Division of 21st Centry Oncology

Fort Myers, Florida, 33907, United States

Location

Florida Cancer Specialists - Sarah Cannon Research Institute

Sarasota, Florida, 34236, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Cancer Center of Middle Georgia, LLC

Dublin, Georgia, 31021, United States

Location

Hawaii Cancer Care

Honolulu, Hawaii, 96813, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

OSF Little Company of Mary Hospital

Evergreen Park, Illinois, 60805, United States

Location

Joliet Oncology-Hematology Associates

Joliet, Illinois, 60435, United States

Location

Edward-Elmhurst Healthcare

Naperville, Illinois, 60540, United States

Location

Illinois Cancer Care

Peoria, Illinois, 61615, United States

Location

Quincy Medical Group Cancer Institute

Quincy, Illinois, 62301, United States

Location

Goshen Center for Cancer Care

Goshen, Indiana, 46526, United States

Location

Michiana Hematology Oncology

Mishawaka, Indiana, 46545, United States

Location

Midwest Oncology Associates - Sarah Cannon Research Institute

Overland Park, Kansas, 66215, United States

Location

University of Kansas Medical Center

Westwood, Kansas, 66205, United States

Location

Baptist Health Madisonville

Madisonville, Kentucky, 42431, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Saint Agnes Hospital Cancer Institute

Baltimore, Maryland, 21229, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Great Lakes Cancer Management Specialists

Grosse Pointe Woods, Michigan, 48236, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Boone Hospital Center

Columbia, Missouri, 65201, United States

Location

Mosaic Cancer Care

Saint Joseph, Missouri, 64507, United States

Location

Nebraska Hematology Oncology

Lincoln, Nebraska, 68506, United States

Location

Callahan Cancer Center

North Platte, Nebraska, 69101, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Bayonne Medical Center

Bayonne, New Jersey, 07002, United States

Location

CarePoint Health - Christ Hospital

Jersey City, New Jersey, 07306, United States

Location

Penn Medicine, Princeton Health

Plainsboro, New Jersey, 08536, United States

Location

Hematology Oncology Associates of Central New York

East Syracuse, New York, 13057, United States

Location

Northwell Health Cancer Institute

Lake Success, New York, 11042, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Levine Cancer Institute Atrium Health

Charlotte, North Carolina, 28204, United States

Location

East Carolina University

Greenville, North Carolina, 27858, United States

Location

Carteret Health Care

Morehead City, North Carolina, 28557, United States

Location

CarolinaEast Medical Center

New Bern, North Carolina, 28560, United States

Location

Regional Medical Oncology Center

Wilson, North Carolina, 27893, United States

Location

Aultman Hospital

Canton, Ohio, 44710, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

University Hospitals Seidman Cancer Center

Cleveland, Ohio, 44106, United States

Location

TriCounty Hematology and Oncology

Massillon, Ohio, 44646, United States

Location

Columbia Memorial Hospital

Astoria, Oregon, 97103, United States

Location

Samaritan Health Services Corvallis

Corvallis, Oregon, 97330, United States

Location

Penn Medicine, Lancaster General Health

Lancaster, Pennsylvania, 17604, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Lexington Oncology

West Columbia, South Carolina, 29169, United States

Location

Monument Health

Rapid City, South Dakota, 57701, United States

Location

Kirkland Cancer Center

Jackson, Tennessee, 38301, United States

Location

Baptist Clinical Research Institute

Memphis, Tennessee, 38120, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

The START Center for Cancer Care

San Antonio, Texas, 78229, United States

Location

University of Texas, Health Science Center

San Antonio, Texas, 78229, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Augusta Health

Fishersville, Virginia, 22939, United States

Location

Hematology Oncology Associates of Fredericksburg

Fredericksburg, Virginia, 22408, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23230, United States

Location

PeaceHealth

Vancouver, Washington, 98664, United States

Location

Related Publications (5)

  • Mullangi S, Aviki EM, Hershman DL. Reexamining Social Determinants of Health Data Collection in the COVID-19 Era. JAMA Oncol. 2022 Dec 1;8(12):1736-1738. doi: 10.1001/jamaoncol.2022.4543.

    PMID: 36301554BACKGROUND
  • Kurbegov D, Bruinooge SS, Lei XJ, Kirkwood MK, Dickson N, Hattiangadi T, Mileham KF, Patrick A, Williams JH, Kaltenbaugh M, Gralow JR, Garrett-Mayer E. Rate of COVID-19 vaccination among patients with cancer who tested positive for severe acute respiratory syndrome-coronavirus 2: Analysis of the American Society of Clinical Oncology Registry. Cancer. 2023 Jun 1;129(11):1752-1762. doi: 10.1002/cncr.34726. Epub 2023 Mar 15.

  • Mileham KF, Bruinooge SS, Aggarwal C, Patrick AL, Davis C, Mesenhowski DJ, Spira A, Clayton EJ, Waterhouse D, Moore S, Jazieh AR, Chen RC, Kaltenbaugh M, Williams JH, Gralow JR, Schilsky RL, Garrett-Mayer E. Changes Over Time in COVID-19 Severity and Mortality in Patients Undergoing Cancer Treatment in the United States: Initial Report From the ASCO Registry. JCO Oncol Pract. 2022 Apr;18(4):e426-e441. doi: 10.1200/OP.21.00394. Epub 2021 Oct 25.

  • Llanos AAM, Ashrafi A, Ghosh N, Tsui J, Lin Y, Fong AJ, Ganesan S, Heckman CJ. Evaluation of Inequities in Cancer Treatment Delay or Discontinuation Following SARS-CoV-2 Infection. JAMA Netw Open. 2023 Jan 3;6(1):e2251165. doi: 10.1001/jamanetworkopen.2022.51165.

  • Mullangi S, Aviki EM, Chen Y, Robson M, Hershman DL. Factors Associated With Cancer Treatment Delay Among Patients Diagnosed With COVID-19. JAMA Netw Open. 2022 Jul 1;5(7):e2224296. doi: 10.1001/jamanetworkopen.2022.24296.

MeSH Terms

Conditions

NeoplasmsCoronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Julie R Gralow, MD

    American Society of Clinical Oncology

    PRINCIPAL INVESTIGATOR
  • Suanna S Bruinooge, MPH

    American Society of Clinical Oncology

    STUDY DIRECTOR
  • Elizabeth Garrett-Mayer, PhD

    American Society of Clinical Oncology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 9, 2020

Study Start

April 19, 2020

Primary Completion

August 1, 2024

Study Completion

January 1, 2025

Last Updated

July 24, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

ASCO is making deidentified Registry data available to researchers (both those at Registry sites and those not involved with the Registry) who submit a qualified research proposal for further analysis. ASCO reviews requests for Registry data from individuals and entities that submit a research proposal that complies with ASCO's requirements for data access. ASCO will promote access to information for projects that address the needs of patients with cancer, including marginalized populations and communities. ASCO will promote authenticity, quality, reliability and integrity of information and analyses. ASCO will promote fair access and efficiency in the use and sharing of ASCO Information within the bounds of this Policy.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
First Quarter 2022
Access Criteria
Completion of a satisfactory Research Project Proposal Application, as discussed on the ASCO Data Library website
More information

Locations