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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 : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Jeremy Warner, 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.

Condition or disease Intervention/treatment
COVID-19 Invasive Malignancy (Any Type) Other: Web-based REDCap survey

Detailed Description:
The primary goal of this is to 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. No protected health information (PHI), as defined by the Health Insurance Portability and Accountability Act of 1996 (HIPAA), will be collected by this centralized registry.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: The COVID-19 and Cancer Consortium (CCC19) Registry
Actual Study Start Date : March 17, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from the COVID-19 and Cancer Consortium (CCC19).
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04354701


Contacts
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Contact: Vanderbilt-Ingram Service for Timely Access 800-811-8480 cip@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Sanjay Mishra, PhD    615-875-9806    sanjay.mishra.1@vumc.org   
Principal Investigator: Jeremy Warner, MD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
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Principal Investigator: Jeremy Warner, MD Vanderbilt-Ingram Cancer Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeremy Warner, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT04354701    
Other Study ID Numbers: VICC MD 2032
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms