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

ASCO Survey on Coronavirus Disease 2019 (COVID-19) in Oncology (ASCO) Registry

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neoplasms; Coronavirus

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.

• Study Type: Observational
• Enrollment (Estimated): 7000

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
    • Mobile, Alabama, United States, 36607
      • Infirmary Cancer Care
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Anchorage Oncology Center
  • California
    • Bakersfield, California, United States, 93301
      • AIS Cancer Center
    • Fountain Valley, California, United States, 92708
      • Long Beach Memorial Medical Center
    • Fountain Valley, California, United States, 92708
      • Orange Coast Medical Center
    • Fountain Valley, California, United States, 92708
      • Saddleback Memorial Medical Center
    • San Francisco, California, United States, 94118
      • Helen Diller Family Comprehensive Cancer Center, UCSF
    • Truckee, California, United States, 96161
      • Gene Upshaw Memorial Tahoe Forest Cancer Center
    • Whittier, California, United States, 90602
      • PIH Health
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford HealthCare Cancer Institute
    • Putnam, Connecticut, United States, 06260
      • Day Kimball Healthcare
  • Delaware
    • Dover, Delaware, United States, 19901
      • Bayhealth Medical Center
  • Florida
    • Fort Myers, Florida, United States, 33907
      • Florida Precision Oncology, A Division of 21st Centry Oncology
    • Sarasota, Florida, United States, 34236
      • Florida Cancer Specialists - Sarah Cannon Research Institute
    • Tampa, Florida, United States, 33612
      • University of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Winship Cancer Institute
    • Augusta, Georgia, United States, 30912
      • Augusta University
    • Dublin, Georgia, United States, 31021
      • Cancer Center of Middle Georgia, LLC
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Hawaii Cancer Care
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Evanston, Illinois, United States, 60201
      • NorthShore University HealthSystem
    • Evergreen Park, Illinois, United States, 60805
      • OSF Little Company of Mary Hospital
    • Joliet, Illinois, United States, 60435
      • Joliet Oncology-Hematology Associates
    • Naperville, Illinois, United States, 60540
      • Edward-Elmhurst Healthcare
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care
    • Quincy, Illinois, United States, 62301
      • Quincy Medical Group Cancer Institute
  • Indiana
    • Goshen, Indiana, United States, 46526
      • Goshen Center for Cancer Care
    • Mishawaka, Indiana, United States, 46545
      • Michiana Hematology Oncology
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Midwest Oncology Associates - Sarah Cannon Research Institute
    • Westwood, Kansas, United States, 66205
      • University of Kansas Medical Center
  • Kentucky
    • Madisonville, Kentucky, United States, 42431
      • Baptist Health Madisonville
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Greater Baltimore Medical Center
    • Baltimore, Maryland, United States, 21229
      • Saint Agnes Hospital Cancer Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Grosse Pointe Woods, Michigan, United States, 48236
      • Great Lakes Cancer Management Specialists
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Boone Hospital Center
    • Saint Joseph, Missouri, United States, 64507
      • Mosaic Cancer Care
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Nebraska Hematology Oncology
    • North Platte, Nebraska, United States, 69101
      • Callahan Cancer Center
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
    • Omaha, Nebraska, United States, 68130
      • Nebraska Cancer Specialists
  • New Jersey
    • Bayonne, New Jersey, United States, 07002
      • Bayonne Medical Center
    • Jersey City, New Jersey, United States, 07306
      • CarePoint Health - Christ Hospital
    • Plainsboro, New Jersey, United States, 08536
      • Penn Medicine, Princeton Health
  • New York
    • East Syracuse, New York, United States, 13057
      • Hematology Oncology Associates of Central New York
    • Lake Success, New York, United States, 11042
      • Northwell Health Cancer Institute
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute Atrium Health
    • Greenville, North Carolina, United States, 27858
      • East Carolina University
    • Morehead City, North Carolina, United States, 28557
      • Carteret Health Care
    • New Bern, North Carolina, United States, 28560
      • CarolinaEast Medical Center
    • Wilson, North Carolina, United States, 27893
      • Regional Medical Oncology Center
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Hospital
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Seidman Cancer Center
    • Massillon, Ohio, United States, 44646
      • TriCounty Hematology and Oncology
  • Oregon
    • Astoria, Oregon, United States, 97103
      • Columbia Memorial Hospital
    • Corvallis, Oregon, United States, 97330
      • Samaritan Health Services Corvallis
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
      • Penn Medicine, Lancaster General Health
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Lexington Oncology
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Monument Health
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Kirkland Cancer Center
    • Memphis, Tennessee, United States, 38120
      • Baptist Clinical Research Institute
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology
  • Texas
    • San Antonio, Texas, United States, 78229
      • The START Center for Cancer Care
    • San Antonio, Texas, United States, 78229
      • University of Texas, Health Science Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists
    • Fishersville, Virginia, United States, 22939
      • Augusta Health
    • Fredericksburg, Virginia, United States, 22408
      • Hematology Oncology Associates of Fredericksburg
    • Richmond, Virginia, United States, 23230
      • Virginia Cancer Institute
  • Washington
    • Vancouver, Washington, United States, 98664
      • PeaceHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes to Cancer Treatments	Treatments: Yes vs. no response to changes in reported treatment administration for anti-cancer therapeutics	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality at 30 days	Any patient deaths that occurred as measured by number of days after COVID-19 diagnosis	30 days
COVID-19 Symptoms	Yes vs. no response to reported COVID-19 symptoms	24 months
COVID-19 Treatments	Yes vs. no response to reported treatment administration for anti-COVID-19 therapeutics	24 months
Patient vital status	Alive vs. dead up to 24 months from COVID-19 diagnosis	24 months
Overall survival	Time to event endpoint measured as the time from covid-19 dx to death, censored at the last time patient was known to be alive if there is no death date provided.	24 months
Patient cancer status (for patients who had active cancer at covid-19 dx)	Categorical variable of cancer status, compared to time at COVID-19 diagnosis (stable, responding to therapy, progressed). This will be measured over time (longitudinally) and can take different values for the same patient at different time points.	24 months
Patient cancer status (for patients who are disease-free at COVID-19 diagnosis)	An indicator (yes v no) of whether the patients cancer has relapsed since COVID-19 diagnosis. This will be measured over time (longitudinally) and can take different values for the same patient at different time points.	24 months

Collaborators and Investigators

• Sponsor: American Society of Clinical Oncology
• Investigators: Principal Investigator: Julie R Gralow, MD, American Society of Clinical Oncology; Study Director: Suanna S Bruinooge, MPH, American Society of Clinical Oncology; Study Director: Elizabeth Garrett-Mayer, PhD, American Society of Clinical Oncology

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• ASCO website for the ASCO Survey on COVID-19 in Oncology (ASCO) Registry.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2020
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Cancer
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: Pro00014181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: First Quarter 2022
• IPD Sharing Access Criteria: Completion of a satisfactory Research Project Proposal Application, as discussed on the ASCO Data Library website
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No