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

Status
Active
Cancer Type
COVID-19
Hematopoietic Malignancies
Solid Tumor
Trial Phase
Eligibility
0 Years and older, Male and Female
Study Type
Other
NCT ID
NCT04659135
Protocol IDs
Pro00014181 (primary)
NCI-2021-00737
Study Sponsor
American Society of Clinical Oncology

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 is
designed to collect both baseline and follow-up data on how the virus impacts cancer care and
cancer patient outcomes during the COVID-19 pandemic and into 2021.

Objectives

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) will periodically create reports to share
with participating practices and the general cancer community, and submit manuscripts for
publication. Reports will 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

  1. COVID-19 positive diagnosis
  2. One of the following;
  3. Patient has active cancer at the time of COVID-19 diagnosis OR
  4. Patient has been cancer-free for less than 12 months AND receiving adjuvant therapy at the time of COVID-19 diagnosis
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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