Clinical trial NCT04659135: ASCO Survey on COVID-19 in Oncology (ASCO) Registry
Official title: ASCO Survey on Coronavirus Disease 2019 (COVID-19) in Oncology (ASCO) Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Neoplasms
Coronavirus
Keywords: Cancer
Lead sponsor: American Society of Clinical Oncology
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 7000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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.

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

Primary outcomes:
measure: Changes to Cancer Treatments
timeFrame: 24 months
Secondary outcomes:
measure: All-cause mortality at 30 days
timeFrame: 30 days
measure: COVID-19 Symptoms
timeFrame: 24 months
measure: COVID-19 Treatments
timeFrame: 24 months
measure: Patient vital status
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
measure: Patient cancer status (for patients who had active cancer at covid-19 dx)
timeFrame: 24 months
measure: Patient cancer status (for patients who are disease-free at COVID-19 diagnosis)
timeFrame: 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mobile
country: United States
facility: Infirmary Cancer Care
state: Alabama
city: Anchorage
country: United States
facility: Anchorage Oncology Center
state: Alaska
city: Bakersfield
country: United States
facility: AIS Cancer Center
state: California
city: Fountain Valley
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Fountain Valley
country: United States
facility: Orange Coast Medical Center
state: California
city: Fountain Valley
country: United States
facility: Saddleback Memorial Medical Center
state: California
city: San Francisco
country: United States
facility: Helen Diller Family Comprehensive Cancer Center, UCSF
state: California
city: Truckee
country: United States
facility: Gene Upshaw Memorial Tahoe Forest Cancer Center
state: California
city: Whittier
country: United States
facility: PIH Health
state: California
city: Hartford
country: United States
facility: Hartford HealthCare Cancer Institute
state: Connecticut
city: Putnam
country: United States
facility: Day Kimball Healthcare
state: Connecticut
city: Dover
country: United States
facility: Bayhealth Medical Center
state: Delaware
city: Fort Myers
country: United States
facility: Florida Precision Oncology, A Division of 21st Centry Oncology
state: Florida
city: Sarasota
country: United States
facility: Florida Cancer Specialists - Sarah Cannon Research Institute
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Dublin
country: United States
facility: Cancer Center of Middle Georgia, LLC
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Cancer Care
state: Hawaii
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Evergreen Park
country: United States
facility: OSF Little Company of Mary Hospital
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates
state: Illinois
city: Naperville
country: United States
facility: Edward-Elmhurst Healthcare
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Quincy
country: United States
facility: Quincy Medical Group Cancer Institute
state: Illinois
city: Goshen
country: United States
facility: Goshen Center for Cancer Care
state: Indiana
city: Mishawaka
country: United States
facility: Michiana Hematology Oncology
state: Indiana
city: Overland Park
country: United States
facility: Midwest Oncology Associates - Sarah Cannon Research Institute
state: Kansas
city: Westwood
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Madisonville
country: United States
facility: Baptist Health Madisonville
state: Kentucky
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Saint Agnes Hospital Cancer Institute
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Grosse Pointe Woods
country: United States
facility: Great Lakes Cancer Management Specialists
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Columbia
country: United States
facility: Boone Hospital Center
state: Missouri
city: Saint Joseph
country: United States
facility: Mosaic Cancer Care
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Hematology Oncology
state: Nebraska
city: North Platte
country: United States
facility: Callahan Cancer Center
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Bayonne
country: United States
facility: Bayonne Medical Center
state: New Jersey
city: Jersey City
country: United States
facility: CarePoint Health - Christ Hospital
state: New Jersey
city: Plainsboro
country: United States
facility: Penn Medicine, Princeton Health
state: New Jersey
city: East Syracuse
country: United States
facility: Hematology Oncology Associates of Central New York
state: New York
city: Lake Success
country: United States
facility: Northwell Health Cancer Institute
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute Atrium Health
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Morehead City
country: United States
facility: Carteret Health Care
state: North Carolina
city: New Bern
country: United States
facility: CarolinaEast Medical Center
state: North Carolina
city: Wilson
country: United States
facility: Regional Medical Oncology Center
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Seidman Cancer Center
state: Ohio
city: Massillon
country: United States
facility: TriCounty Hematology and Oncology
state: Ohio
city: Astoria
country: United States
facility: Columbia Memorial Hospital
state: Oregon
city: Corvallis
country: United States
facility: Samaritan Health Services Corvallis
state: Oregon
city: Lancaster
country: United States
facility: Penn Medicine, Lancaster General Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: West Columbia
country: United States
facility: Lexington Oncology
state: South Carolina
city: Rapid City
country: United States
facility: Monument Health
state: South Dakota
city: Jackson
country: United States
facility: Kirkland Cancer Center
state: Tennessee
city: Memphis
country: United States
facility: Baptist Clinical Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: San Antonio
country: United States
facility: The START Center for Cancer Care
state: Texas
city: San Antonio
country: United States
facility: University of Texas, Health Science Center
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Fishersville
country: United States
facility: Augusta Health
state: Virginia
city: Fredericksburg
country: United States
facility: Hematology Oncology Associates of Fredericksburg
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Vancouver
country: United States
facility: PeaceHealth
state: Washington
Study officials:
affiliation: American Society of Clinical Oncology
name: Julie R Gralow, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: American Society of Clinical Oncology
name: Suanna S Bruinooge, MPH
role: STUDY_DIRECTOR
affiliation: American Society of Clinical Oncology
name: Elizabeth Garrett-Mayer, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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 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.
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.2022.51165.
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.