ColoCare Study - Colorectal Cancer Cohort

Last updated: June 10, 2025
Sponsor: University of Utah
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rectal Cancer

Colon Cancer

Colon Cancer; Rectal Cancer

Treatment

N/A

Clinical Study ID

NCT02328677
6407
  • Ages 18-89
  • All Genders

Study Summary

ColoCare is an international prospective cohort study of stage I-IV colorectal cancer patients (ICD-10 C18-C20).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-89 years; for patients recruited after 09/01/2021 the age range is 18-69years. Recruitment of patients 70 years and older was maintained for specificsub-studies and re-initiated for specific R01 grant funding in ~06/2024

  2. Men and women

  3. Newly-diagnosed colon or rectal cancer (stages I-IV); CRC in treatment (FHCRC andHCI)

  4. English (FHCRC, Moffitt, HCI, Cedars-Sinai, WashU St. Louis) or German (UniversityHospital Heidelberg)-speaking;

  5. mentally/physically able to consent and participate.

Exclusion

Exclusion Criteria:

  • if one of the above in not fulfilled

  • insufficient language or consent capacity

Study Design

Total Participants: 5000
Study Start date:
March 01, 2007
Estimated Completion Date:
October 31, 2030

Study Description

The ColoCare Study 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 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).

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 sub-studies or in studies for older cancer patients. Recruitment of patients >70 years was re-initiated after 06/2024 in anticipation of R01 grant funding.

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 (early-onset 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.

Connect with a study center

  • University Hospital Heidelberg

    Heidelberg, Baden-Württemberg 69120
    Germany

    Active - Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Lee H. Moffitt Cancer Center

    Tampa, Florida 12902
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63112
    United States

    Active - Recruiting

  • University of Tennessee

    Knoxville, Tennessee 37996
    United States

    Active - Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • FHCRC

    Seattle, Washington 98109-1024
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.