COVID-19 and Cancer Consortium Registry

Active, not recruiting

• Conditions: Invasive Malignancy (Any Type); COVID-19

• Registration Number: NCT04354701
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

In this study we will collect granular information on cancer patients infected with COVID-19, as rapidly as possible. The mechanism for collection of this information is a de-identified centralized registry housed at Vanderbilt University Medical Center, with data donations from internal and external health care professionals.

Detailed Description

The COVID-19 and Cancer Consortium (CCC19) registry prospectively collects anonymized data about patients diagnosed with COVID-19 and cancer. The goal of the registry is to generate hypothesis-generating and hypothesis-supporting findings that are generalizable to the population at large. Specifically:

I. Characterize patient factors, such as pre-existing comorbidities, baseline medication exposures, cancer type, status, and treatment, and demographic factors that are associated with short- and long-term outcomes of COVID-19 (laboratory-confirmed or presumptive), including severity and fatality, in patients with cancer.

II. Describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation.

III. Evaluate the association of COVID-19 with cancer outcomes.

Study Timeline

• Study Start: 2020-03-17
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-06
• Last Update Posted: 2024-01-09
• Primary Completion: 2028-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 19275

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Web-based REDCap survey	Approximately 18 months	The survey includes five parts: 1) basic demographics about the patient, including performance status and comorbidities; 2) initial COVID-19 diagnosis and clinical course; 3) cancer and cancer treatment details; 4) respondent details; 5) long-term COVID-19 outcomes.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States