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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04659135
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
American Society of Clinical Oncology

Study Description
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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.

Condition or disease
Neoplasms Coronavirus

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Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 7000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: ASCO Survey on Coronavirus Disease 2019 (COVID-19) in Oncology (ASCO) Registry
Actual Study Start Date : April 19, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Changes to Cancer Treatments [ Time Frame: 24 months ]
    Treatments: Yes vs. no response to changes in reported treatment administration for anti-cancer therapeutics


Secondary Outcome Measures :
  1. All-cause mortality at 30 days [ Time Frame: 30 days ]
    Any patient deaths that occurred as measured by number of days after COVID-19 diagnosis

  2. COVID-19 Symptoms [ Time Frame: 24 months ]
    Yes vs. no response to reported COVID-19 symptoms

  3. COVID-19 Treatments [ Time Frame: 24 months ]
    Yes vs. no response to reported treatment administration for anti-COVID-19 therapeutics

  4. Patient vital status [ Time Frame: 24 months ]
    Alive vs. dead up to 24 months from COVID-19 diagnosis

  5. Overall survival [ Time Frame: 24 months ]
    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.

  6. Patient cancer status (for patients who had active cancer at covid-19 dx) [ Time Frame: 24 months ]
    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.

  7. Patient cancer status (for patients who are disease-free at COVID-19 diagnosis) [ Time Frame: 24 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04659135


Contacts
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Contact: Jen H Williams, MA 571-483-3000 centra@asco.org

Locations
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Sponsors and Collaborators
American Society of Clinical Oncology
Investigators
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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
  Study Documents (Full-Text)

Documents provided by American Society of Clinical Oncology:
Study Protocol  [PDF] October 6, 2020

More Information
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Responsible Party: American Society of Clinical Oncology
ClinicalTrials.gov Identifier: NCT04659135    
Other Study ID Numbers: Pro00014181
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: ASCO will make deidentified Registry data available to researchers (both those at Registry sites and those not involved with the Registry) for further analysis. The timing of data release will depend on the number of cases reported to the registry, and entry of the outcome information. ASCO will review 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: First Quarter 2022
Access Criteria: Completion of a satisfactory Research Project Proposal Application, as discussed on the ASCO Data Library website (https://www.asco.org/research-guidelines/center-research-analytics-centra/asco-data-library)
URL: https://www.asco.org/covid-resources/asco-registry

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by American Society of Clinical Oncology:
Cancer
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Virus Diseases
Infections