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COVID-19 and Cancer Consortium Registry (CCC19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04354701
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : September 9, 2021
Sponsor:
Information provided by (Responsible Party):
Jeremy Warner, Vanderbilt-Ingram Cancer Center

Tracking Information
First Submitted Date April 16, 2020
First Posted Date April 21, 2020
Last Update Posted Date September 9, 2021
Actual Study Start Date March 17, 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 16, 2020)
Web-based REDCap survey [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title COVID-19 and Cancer Consortium Registry
Official Title The COVID-19 and Cancer Consortium (CCC19) Registry
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 Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 36 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants will be recruited from the COVID-19 and Cancer Consortium (CCC19).
Condition
  • 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.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 25, 2021)
15000
Original Estimated Enrollment
 (submitted: April 16, 2020)
1000
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Vanderbilt-Ingram Service for Timely Access 800-811-8480 cip@vumc.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04354701
Other Study ID Numbers VICC MD 2032
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 Not Provided
Responsible Party Jeremy Warner, Vanderbilt-Ingram Cancer Center
Study Sponsor Vanderbilt-Ingram Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Jeremy Warner, MD Vanderbilt-Ingram Cancer Center
PRS Account Vanderbilt-Ingram Cancer Center
Verification Date August 2021