Study Results
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Basic Information
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UNKNOWN
7000 participants
OBSERVATIONAL
2020-04-19
2025-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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American Society of Clinical Oncology
OTHER
Responsible Party
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Principal Investigators
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Julie R Gralow, MD
Role: PRINCIPAL_INVESTIGATOR
American Society of Clinical Oncology
Suanna S Bruinooge, MPH
Role: STUDY_DIRECTOR
American Society of Clinical Oncology
Elizabeth Garrett-Mayer, PhD
Role: STUDY_DIRECTOR
American Society of Clinical Oncology
Locations
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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
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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Pro00014181
Identifier Type: -
Identifier Source: org_study_id
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