COVID-19 and Cancer Consortium Registry (CCC19)

The COVID-19 and Cancer Consortium (CCC19) Registry

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19; Invasive Malignancy (Any Type)
• Intervention / Treatment: Other: Web-based REDCap survey

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
• Enrollment (Actual): 19275

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the COVID-19 and Cancer Consortium (CCC19).

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Investigators: Principal Investigator: Jeremy Warner, MD, Vanderbilt-Ingram Cancer Center

Publications and helpful links

General Publications

• Grivas P, Khaki AR, Wise-Draper TM, French B, Hennessy C, Hsu CY, Shyr Y, Li X, Choueiri TK, Painter CA, Peters S, Rini BI, Thompson MA, Mishra S, Rivera DR, Acoba JD, Abidi MZ, Bakouny Z, Bashir B, Bekaii-Saab T, Berg S, Bernicker EH, Bilen MA, Bindal P, Bishnoi R, Bouganim N, Bowles DW, Cabal A, Caimi PF, Chism DD, Crowell J, Curran C, Desai A, Dixon B, Doroshow DB, Durbin EB, Elkrief A, Farmakiotis D, Fazio A, Fecher LA, Flora DB, Friese CR, Fu J, Gadgeel SM, Galsky MD, Gill DM, Glover MJ, Goyal S, Grover P, Gulati S, Gupta S, Halabi S, Halfdanarson TR, Halmos B, Hausrath DJ, Hawley JE, Hsu E, Huynh-Le M, Hwang C, Jani C, Jayaraj A, Johnson DB, Kasi A, Khan H, Koshkin VS, Kuderer NM, Kwon DH, Lammers PE, Li A, Loaiza-Bonilla A, Low CA, Lustberg MB, Lyman GH, McKay RR, McNair C, Menon H, Mesa RA, Mico V, Mundt D, Nagaraj G, Nakasone ES, Nakayama J, Nizam A, Nock NL, Park C, Patel JM, Patel KG, Peddi P, Pennell NA, Piper-Vallillo AJ, Puc M, Ravindranathan D, Reeves ME, Reuben DY, Rosenstein L, Rosovsky RP, Rubinstein SM, Salazar M, Schmidt AL, Schwartz GK, Shah MR, Shah SA, Shah C, Shaya JA, Singh SRK, Smits M, Stockerl-Goldstein KE, Stover DG, Streckfuss M, Subbiah S, Tachiki L, Tadesse E, Thakkar A, Tucker MD, Verma AK, Vinh DC, Weiss M, Wu JT, Wulff-Burchfield E, Xie Z, Yu PP, Zhang T, Zhou AY, Zhu H, Zubiri L, Shah DP, Warner JL, Lopes G. Association of clinical factors and recent anticancer therapy with COVID-19 severity among patients with cancer: a report from the COVID-19 and Cancer Consortium. Ann Oncol. 2021 Jun;32(6):787-800. doi: 10.1016/j.annonc.2021.02.024. Epub 2021 Mar 19.
• Kuderer NM, Choueiri TK, Shah DP, Shyr Y, Rubinstein SM, Rivera DR, Shete S, Hsu CY, Desai A, de Lima Lopes G Jr, Grivas P, Painter CA, Peters S, Thompson MA, Bakouny Z, Batist G, Bekaii-Saab T, Bilen MA, Bouganim N, Larroya MB, Castellano D, Del Prete SA, Doroshow DB, Egan PC, Elkrief A, Farmakiotis D, Flora D, Galsky MD, Glover MJ, Griffiths EA, Gulati AP, Gupta S, Hafez N, Halfdanarson TR, Hawley JE, Hsu E, Kasi A, Khaki AR, Lemmon CA, Lewis C, Logan B, Masters T, McKay RR, Mesa RA, Morgans AK, Mulcahy MF, Panagiotou OA, Peddi P, Pennell NA, Reynolds K, Rosen LR, Rosovsky R, Salazar M, Schmidt A, Shah SA, Shaya JA, Steinharter J, Stockerl-Goldstein KE, Subbiah S, Vinh DC, Wehbe FH, Weissmann LB, Wu JT, Wulff-Burchfield E, Xie Z, Yeh A, Yu PP, Zhou AY, Zubiri L, Mishra S, Lyman GH, Rini BI, Warner JL; COVID-19 and Cancer Consortium. Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study. Lancet. 2020 Jun 20;395(10241):1907-1918. doi: 10.1016/S0140-6736(20)31187-9. Epub 2020 May 28. Erratum In: Lancet. 2020 Sep 12;396(10253):758.
• Bakouny Z, Labaki C, Grover P, Awosika J, Gulati S, Hsu CY, Alimohamed SI, Bashir B, Berg S, Bilen MA, Bowles D, Castellano C, Desai A, Elkrief A, Eton OE, Fecher LA, Flora D, Galsky MD, Gatti-Mays ME, Gesenhues A, Glover MJ, Gopalakrishnan D, Gupta S, Halfdanarson TR, Hayes-Lattin B, Hendawi M, Hsu E, Hwang C, Jandarov R, Jani C, Johnson DB, Joshi M, Khan H, Khan SA, Knox N, Koshkin VS, Kulkarni AA, Kwon DH, Matar S, McKay RR, Mishra S, Moria FA, Nizam A, Nock NL, Nonato TK, Panasci J, Pomerantz L, Portuguese AJ, Provenzano D, Puc M, Rao YJ, Rhodes TD, Riely GJ, Ripp JJ, Rivera AV, Ruiz-Garcia E, Schmidt AL, Schoenfeld AJ, Schwartz GK, Shah SA, Shaya J, Subbiah S, Tachiki LM, Tucker MD, Valdez-Reyes M, Weissmann LB, Wotman MT, Wulff-Burchfield EM, Xie Z, Yang YJ, Thompson MA, Shah DP, Warner JL, Shyr Y, Choueiri TK, Wise-Draper TM; COVID-19 and Cancer Consortium. Interplay of Immunosuppression and Immunotherapy Among Patients With Cancer and COVID-19. JAMA Oncol. 2023 Jan 1;9(1):128-134. doi: 10.1001/jamaoncol.2022.5357.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2020
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 6, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: VICC MD 2032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No