COVID-19 and Cancer Consortium Registry

COVID-19 Clinical Trial

— CCC19  

Official title:

The COVID-19 and Cancer Consortium (CCC19) Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04354701
• Other study ID #: VICC MD 2032
• Status: Active, not recruiting
• Start date: March 17, 2020
• Est. completion date: December 2029

Study information

• Verified date: January 2024
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19275
• Est. completion date: December 2029
• Est. primary completion date: December 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Healthcare providers or their proxies who would like to report a patient with ALL of the following criteria:

• Suspected (presumptive positive based on clinical presentation) or lab-confirmed COVID-19.

• Current or past medical history of invasive malignancy (any type)

Exclusion criteria:

• Participants at international sites not explicitly listed below

• Non-healthcare providers (or their proxies)

Related Conditions & MeSH terms

• COVID-19
• Invasive Malignancy (Any Type)

Intervention

Other:
• Web-based REDCap survey
The survey takes approximately 5-10 minutes to complete and 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Web-based REDCap survey	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.	Approximately 18 months