Fountain Valley, California 92708

  • Coronavirus

Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

Pro00014181


NCT ID:

NCT04659135


Secondary ID:


Study Acronym:


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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

American Society of Clinical Oncology


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Observational [Patient Registry]


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

7000


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Julie R Gralow, MD
Principal Investigator
American Society of Clinical Oncology
Primary Contact:Jen H Williams, MA
571-483-3000
centra@asco.org

Study Dates

Start Date:April 19, 2020
Completion Date:December 2025
Completion Type:Anticipated
Primary Completion Date:December 2024
Primary Completion Type:Anticipated
Verification Date:February 2022
Last Changed Date:February 23, 2022
First Received Date:November 30, 2020

Study Outcomes

Outcome Type:Primary Outcome
Measure:Changes to Cancer Treatments
Time Frame:24 months
Safety Issues:False
Description:Treatments: Yes vs. no response to changes in reported treatment administration for anti-cancer therapeutics
Outcome Type:Secondary Outcome
Measure:All-cause mortality at 30 days
Time Frame:30 days
Safety Issues:False
Description:Any patient deaths that occurred as measured by number of days after COVID-19 diagnosis
Outcome Type:Secondary Outcome
Measure:COVID-19 Symptoms
Time Frame:24 months
Safety Issues:False
Description:Yes vs. no response to reported COVID-19 symptoms
Outcome Type:Secondary Outcome
Measure:COVID-19 Treatments
Time Frame:24 months
Safety Issues:False
Description:Yes vs. no response to reported treatment administration for anti-COVID-19 therapeutics
Outcome Type:Secondary Outcome
Measure:Patient vital status
Time Frame:24 months
Safety Issues:False
Description:Alive vs. dead up to 24 months from COVID-19 diagnosis
Outcome Type:Secondary Outcome
Measure:Overall survival
Time Frame:24 months
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Patient cancer status (for patients who had active cancer at covid-19 dx)
Time Frame:24 months
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Patient cancer status (for patients who are disease-free at COVID-19 diagnosis)
Time Frame:24 months
Safety Issues:False
Description: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.

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:American Society of Clinical Oncology

Samples and Retentions

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
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: February 02, 2023

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