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AzTrials

COVID-19CCC19NCT04354701

COVID-19 and Cancer Consortium Registry

An observational study of COVID-19 and Invasive Malignancy (Any Type), run by Vanderbilt-Ingram Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19, Invasive Malignancy (Any Type)
What is being tested?
Web-based REDCap survey
How many people
19,275 participants
Where
1 siteUnited States
Study dates
17 Mar 2020to Dec 2029
How long will I take part?
36 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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)

Who cannot join

  • Participants at international sites not explicitly listed below
  • Non-healthcare providers (or their proxies)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: 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.

Read the 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:

  1. 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.

Being tested
Web-based REDCap survey
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web-based REDCap surveyOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Approximately 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2020
  2. Study start17 Mar 2020
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
19,275 participants (actual)
Target duration
36 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04354701
Sponsor's protocol ID
VICC MD 2032
Acronym
CCC19
Status last verified
Jan 2024
First submitted
16 Apr 2020
Last updated
9 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Nagaraj G, Vinayak S, Khaki AR, Sun T, Kuderer NM, Aboulafia DM, Acoba JD, Awosika J, Bakouny Z, Balmaceda NB, Bao T, Bashir B, Berg S, Bilen MA, Bindal P, Blau S, Bodin BE, Borno HT, Castellano C, Choi H, Deeken J, Desai A, Edwin N, Feldman LE, Flora DB, Friese CR, Galsky MD, Gonzalez CJ, Grivas P, Gupta S, Haynam M, Heilman H, Hershman DL, Hwang C, Jani C, Jhawar SR, Joshi M, Kaklamani V, Klein EJ, Knox N, Koshkin VS, Kulkarni AA, Kwon DH, Labaki C, Lammers PE, Lathrop KI, Lewis MA, Li X, Lopes GL, Lyman GH, Makower DF, Mansoor AH, Markham MJ, Mashru SH, McKay RR, Messing I, Mico V, Nadkarni R, Namburi S, Nguyen RH, Nonato TK, O'Connor TL, Panagiotou OA, Park K, Patel JM, Patel KG, Peppercorn J, Polimera H, Puc M, Rao YJ, Razavi P, Reid SA, Riess JW, Rivera DR, Robson M, Rose SJ, Russ AD, Schapira L, Shah PK, Shanahan MK, Shapiro LC, Smits M, Stover DG, Streckfuss M, Tachiki L, Thompson MA, Tolaney SM, Weissmann LB, Wilson G, Wotman MT, Wulff-Burchfield EM, Mishra S, French B, Warner JL, Lustberg MB, Accordino MK, Shah DP; COVID-19 and Cancer Consortium. Clinical characteristics, racial inequities, and outcomes in patients with breast cancer and COVID-19: A COVID-19 and cancer consortium (CCC19) cohort study. Elife. 2023 Oct 17;12:e82618. doi: 10.7554/eLife.82618.

    PubMed 37846664

  • Moey MYY, Hennessy C, French B, Warner JL, Tucker MD, Hausrath DJ, Shah DP, DeCara JM, Bakouny Z, Labaki C, Choueiri TK, Dent S, Akhter N, Ismail-Khan R, Tachiki L, Slosky D, Polonsky TS, Awosika JA, Crago A, Wise-Draper T, Balanchivadze N, Hwang C, Fecher LA, Gomez CG, Hayes-Lattin B, Glover MJ, Shah SA, Gopalakrishnan D, Griffiths EA, Kwon DH, Koshkin VS, Mahmood S, Bashir B, Nonato T, Razavi P, McKay RR, Nagaraj G, Oligino E, Puc M, Tregubenko P, Wulff-Burchfield EM, Xie Z, Halfdanarson TR, Farmakiotis D, Klein EJ, Robilotti EV, Riely GJ, Durand JB, Hayek SS, Kondapalli L, Berg S, O'Connor TE, Bilen MA, Castellano C, Accordino MK, Sibel B, Weissmann LB, Jani C, Flora DB, Rudski L, Dutra MS, Nathaniel B, Ruiz-Garcia E, Vilar-Compte D, Gupta S, Morgans A, Nohria A; COVID-19 and Cancer Consortium. COVID-19 severity and cardiovascular outcomes in SARS-CoV-2-infected patients with cancer and cardiovascular disease. Transl Oncol. 2023 Aug;34:101709. doi: 10.1016/j.tranon.2023.101709. Epub 2023 Jun 2.

    PubMed 37302348

  • 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.

    PubMed 36326731

  • 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.

    PubMed 33746047

  • 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.

    PubMed 32473681

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and Invasive Malignancy (Any Type), run by Vanderbilt-Ingram Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Web-based REDCap survey (time frame: Approximately 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04354701, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.

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