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

• ClinicalTrials.gov Identifier: NCT04659135
• Recruitment Status: Recruiting
• First Posted: December 9, 2020
• Last Update Posted: March 10, 2022
• Sponsor: American Society of Clinical Oncology
• Information provided by (Responsible Party): American Society of Clinical Oncology

Tracking Information

• First Submitted Date: November 30, 2020
• First Posted Date: December 9, 2020
• Last Update Posted Date: March 10, 2022
• Actual Study Start Date: April 19, 2020
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 23, 2022)

Changes to Cancer Treatments [ Time Frame: 24 months ]

Treatments: Yes vs. no response to changes in reported treatment administration for anti-cancer therapeutics

Original Primary Outcome Measures (submitted: December 7, 2020)

Changes to Cancer Treatments [ Time Frame: 12 months ]

Treatments: Yes vs. no response to changes in reported treatment administration for anti-cancer therapeutics

Current Secondary Outcome Measures (submitted: February 23, 2022)

• 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
• COVID-19 Symptoms [ Time Frame: 24 months ]
  Yes vs. no response to reported COVID-19 symptoms
• COVID-19 Treatments [ Time Frame: 24 months ]
  Yes vs. no response to reported treatment administration for anti-COVID-19 therapeutics
• Patient vital status [ Time Frame: 24 months ]
  Alive vs. dead up to 24 months from COVID-19 diagnosis
• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: December 7, 2020)

• 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
• COVID-19 Symptoms [ Time Frame: 12 months ]
  Yes vs. no response to reported COVID-19 symptoms
• COVID-19 Treatments [ Time Frame: 12 months ]
  Yes vs. no response to reported treatment administration for anti-COVID-19 therapeutics
• Patient vital status [ Time Frame: 12 months ]
  Alive vs. dead at 12 months from COVID-19 diagnosis
• Overall survival [ Time Frame: 12 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.
• Patient cancer status (for patients who had active cancer at covid-19 dx) [ Time Frame: 12 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.
• Patient cancer status (for patients who are disease-free at COVID-19 diagnosis) [ Time Frame: 12 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ASCO Survey on COVID-19 in Oncology (ASCO) Registry
• Official Title: ASCO Survey on Coronavirus Disease 2019 (COVID-19) in Oncology (ASCO) Registry
• 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.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: 24 Months
• Biospecimen: Not Provided
• 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

Condition

• Neoplasms
• Coronavirus

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 23, 2022): 7000
• Original Estimated Enrollment (submitted: December 7, 2020): 2000
• Estimated Study Completion Date: December 2025
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04659135
• Other Study ID Numbers: Pro00014181
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: 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

• Current Responsible Party: American Society of Clinical Oncology
• Original Responsible Party: Same as current
• Current Study Sponsor: American Society of Clinical Oncology
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

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

• PRS Account: American Society of Clinical Oncology
• Verification Date: February 2022