ColoCare Study - Colorectal Cancer Cohort
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ClinicalTrials.gov Identifier: NCT02328677 |
Recruitment Status :
Recruiting
First Posted : December 31, 2014
Last Update Posted : May 26, 2022
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Condition or disease |
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Colorectal Cancer |
The ColoCare Consortium is a multicenter initiative establishing an international cohort of colorectal cancer (CRC) patients for interdisciplinary studies of CRC prognosis and outcomes with sites at the Fred Hutchinson Cancer Research Center, Seattle (Washington, USA), H. Lee Moffitt Cancer Center and Research Institute, Tampa (Florida, USA), the University Hospital Heidelberg (Germany), the Huntsman Cancer Institute (Utah, USA), the Cedars-Senai Medical Center (California, USA), University of Washington St. Louis (Missouri, USA), and University of Tennessee (Tennessee, USA). Additional information is provided in the study design paper, that has been published in 2019 (https://pubmed.ncbi.nlm.nih.gov/30523039/).
Aims: The ColoCare Study investigates clinical outcomes, including disease-free and overall survival, predictors of cancer recurrence, survival, health-related quality-of-life and treatment toxicities. In addition, cross-sectional analyses of biomarkers and/or health behaviors are undertaken. Patients will be recruited if their age range is 18-89 years. For patients recruited after 09/01/2021 the age range is between 18-69 years, except if they participate in specific pilot studies.
Patients are recruited at baseline (time of first diagnosis) and followed for up to 5 years at regular timepoints (3m, 6m, 12m, 24m, 36m, 48m, 60m). The cohort includes a comprehensive collection of specimens and data. For the U01 renewal phase (start September 2021) we specifically focus on the recruitment of minorities (young patients, African American patients, Hispanic patients) and patients with rectal cancer. Furthermore, we will have an overall focus on questionnaire assessment at baseline, 12, and 60 months and intensive medical chart abstraction 24 months and 60. months after enrollment into the study.
Study Type : | Observational |
Estimated Enrollment : | 5000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | ColoCare Transdisciplinary Research in Colorectal Cancer Prognosis |
Study Start Date : | March 2007 |
Estimated Primary Completion Date : | October 2030 |
Estimated Study Completion Date : | October 2030 |
Group/Cohort |
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ColoCare FHCRC
Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2021: n=679
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ColoCare Moffitt (affiliated cohort)
Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2021: n=895
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University Hospital Heidelberg
Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2021: n=721
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ColoCare Huntsman Cancer Institute
Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2021: n=394
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Cedars-Sinai Medical Center
Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2021: n=234
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Washington University School of Medicine in St. Louis
Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2021: n=232
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University of Tennessee
Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status August 31, 2021: n=183
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- Disease-free and overall survival [ Time Frame: up to 10 years ]
- Recurrence [ Time Frame: up to 5 years ]
- Health-related quality of life [ Time Frame: at 0, 3, 6, 12, 24, 36, 48, 60 months post recruitment ]
- Treatment toxicities [ Time Frame: up to 5 years post treatment ]
Biospecimen Retention: Samples With DNA

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.
Ages Eligible for Study: | 18 Years to 89 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age 18-89 years; for patients recruited after 09/01/2021 the age range is 18-69 years
- Men and women
- Newly-diagnosed colon or rectal cancer (stages I-IV); CRC in treatment (FHCRC and HCI)
- English (FHCRC, Moffitt, HCI, Cedars-Sinai, WashU St. Louis) or German (University Hospital Heidelberg)-speaking;
- mentally/physically able to consent and participate.
Exclusion Criteria:
- if one of the above in not fulfilled
- insufficient language or consent capacity

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): NCT02328677
Contact: Cornelia Ulrich, MS, PhD | (801) 213-5716 | neli.ulrich@hci.utah.edu | |
Contact: Erin Siegel, PhD | 813-745-6533 | erin.siegel@moffitt.org |
United States, California | |
Cedars-Sinai Medical Center | Recruiting |
Los Angeles, California, United States, 90048 | |
Contact: Jane Figueiredo, PhD janefigu@usc.edu | |
United States, Florida | |
Lee H. Moffitt Cancer Center | Recruiting |
Tampa, Florida, United States, 12902 | |
Contact: Erin Siegel, PhD Erin.siegel@moffitt.org | |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
Saint Louis, Missouri, United States, 63112 | |
Contact: Adetunji T Toriola, MD, PhD a.toriola@wustl.edu | |
United States, Tennessee | |
University of Tennessee | Recruiting |
Knoxville, Tennessee, United States, 37996 | |
Contact: David Shibata, MD dshibata@uthsc.edu | |
United States, Utah | |
Huntsman Cancer Institute | Recruiting |
Salt Lake City, Utah, United States, 84112 | |
Contact: Cornelia Ulrich, MS, PhD neli.ulrich@hci.utah.edu | |
United States, Washington | |
FHCRC | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: Christopher Li, MD, PhD cili@fhcrc.org | |
Contact: William Grady, MD, PhD wgrady@fhcrc.org | |
Germany | |
University Hospital Heidelberg | Recruiting |
Heidelberg, Baden-Württemberg, Germany, 69120 | |
Contact: Martin Schneider, MD Martin.Schneider@med.uni-heidelberg.de |
Principal Investigator: | Cornelia M Ulrich, MS, PhD | Huntsman Cancer Institute | |
Principal Investigator: | William Grady, MD, PhD | Fred Hutchinson Cancer Center | |
Principal Investigator: | Martin Schneider, MD | University Hospital Heidelberg | |
Principal Investigator: | Christopher Li, MD | Fred Hutchinson Cancer Center | |
Principal Investigator: | Erin Siegel, PhD | Lee H. Moffitt Cancer Center | |
Principal Investigator: | Jane Figueiredo, PhD | Cedars-Sinai Medical Center | |
Principal Investigator: | David Shibata, MD | University of Tennesee | |
Principal Investigator: | Adetunji T. Toriola, MD, PhD | Washington University School of Medicine |
Other Publications:
Responsible Party: | Cornelia Ulrich, M.D., University of Utah |
ClinicalTrials.gov Identifier: | NCT02328677 |
Obsolete Identifiers: | NCT02391597 |
Other Study ID Numbers: |
6407 |
First Posted: | December 31, 2014 Key Record Dates |
Last Update Posted: | May 26, 2022 |
Last Verified: | May 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Colorectal cancer rectosigmoid rectum colon |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |