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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04659135
• Other study ID #: Pro00014181
• Status: Active, not recruiting
• Start date: April 19, 2020
• Est. completion date: January 2025

Study information

• Verified date: July 2023
• Source: American Society of Clinical Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7000
• Est. completion date: January 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• Neoplasms

Locations

Country	Name	City	State
United States	Anchorage Oncology Center	Anchorage	Alaska
United States	Columbia Memorial Hospital	Astoria	Oregon
United States	Emory University Winship Cancer Institute	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	AIS Cancer Center	Bakersfield	California
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Saint Agnes Hospital Cancer Institute	Baltimore	Maryland
United States	Bayonne Medical Center	Bayonne	New Jersey
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Tufts Medical Center	Boston	Massachusetts
United States	Aultman Hospital	Canton	Ohio
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	University of Chicago	Chicago	Illinois
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	Boone Hospital Center	Columbia	Missouri
United States	Samaritan Health Services Corvallis	Corvallis	Oregon
United States	Bayhealth Medical Center	Dover	Delaware
United States	Cancer Center of Middle Georgia, LLC	Dublin	Georgia
United States	Hematology Oncology Associates of Central New York	East Syracuse	New York
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	OSF Little Company of Mary Hospital	Evergreen Park	Illinois
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	Augusta Health	Fishersville	Virginia
United States	Florida Precision Oncology, A Division of 21st Centry Oncology	Fort Myers	Florida
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	Hematology Oncology Associates of Fredericksburg	Fredericksburg	Virginia
United States	Goshen Center for Cancer Care	Goshen	Indiana
United States	East Carolina University	Greenville	North Carolina
United States	Great Lakes Cancer Management Specialists	Grosse Pointe Woods	Michigan
United States	Hartford HealthCare Cancer Institute	Hartford	Connecticut
United States	Hawaii Cancer Care	Honolulu	Hawaii
United States	Kirkland Cancer Center	Jackson	Tennessee
United States	CarePoint Health - Christ Hospital	Jersey City	New Jersey
United States	Joliet Oncology-Hematology Associates	Joliet	Illinois
United States	Northwell Health Cancer Institute	Lake Success	New York
United States	Penn Medicine, Lancaster General Health	Lancaster	Pennsylvania
United States	Nebraska Hematology Oncology	Lincoln	Nebraska
United States	Baptist Health Madisonville	Madisonville	Kentucky
United States	TriCounty Hematology and Oncology	Massillon	Ohio
United States	Baptist Clinical Research Institute	Memphis	Tennessee
United States	Michiana Hematology Oncology	Mishawaka	Indiana
United States	Infirmary Cancer Care	Mobile	Alabama
United States	Carteret Health Care	Morehead City	North Carolina
United States	Edward-Elmhurst Healthcare	Naperville	Illinois
United States	Tennessee Oncology	Nashville	Tennessee
United States	CarolinaEast Medical Center	New Bern	North Carolina
United States	Memorial Sloan Kettering Cancer Center	New York	New York
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	Midwest Oncology Associates - Sarah Cannon Research Institute	Overland Park	Kansas
United States	Illinois Cancer Care	Peoria	Illinois
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Penn Medicine, Princeton Health	Plainsboro	New Jersey
United States	Day Kimball Healthcare	Putnam	Connecticut
United States	Quincy Medical Group Cancer Institute	Quincy	Illinois
United States	Monument Health	Rapid City	South Dakota
United States	Virginia Cancer Institute	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Mosaic Cancer Care	Saint Joseph	Missouri
United States	The START Center for Cancer Care	San Antonio	Texas
United States	University of Texas, Health Science Center	San Antonio	Texas
United States	Helen Diller Family Comprehensive Cancer Center, UCSF	San Francisco	California
United States	Florida Cancer Specialists - Sarah Cannon Research Institute	Sarasota	Florida
United States	University of South Florida	Tampa	Florida
United States	Gene Upshaw Memorial Tahoe Forest Cancer Center	Truckee	California
United States	PeaceHealth	Vancouver	Washington
United States	Lexington Oncology	West Columbia	South Carolina
United States	University of Kansas Medical Center	Westwood	Kansas
United States	PIH Health	Whittier	California
United States	Regional Medical Oncology Center	Wilson	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
American Society of Clinical Oncology

Country where clinical trial is conducted

United States, 

References & Publications (5)

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 respirator — View Citation

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.202 — View Citation

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 Mort — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes to Cancer Treatments	Treatments: Yes vs. no response to changes in reported treatment administration for anti-cancer therapeutics	24 months
Secondary	All-cause mortality at 30 days	Any patient deaths that occurred as measured by number of days after COVID-19 diagnosis	30 days
Secondary	COVID-19 Symptoms	Yes vs. no response to reported COVID-19 symptoms	24 months
Secondary	COVID-19 Treatments	Yes vs. no response to reported treatment administration for anti-COVID-19 therapeutics	24 months
Secondary	Patient vital status	Alive vs. dead up to 24 months from COVID-19 diagnosis	24 months
Secondary	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
Secondary	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
Secondary	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

External Links

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