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ColoCare Study - Colorectal Cancer Cohort

ColoCare Transdisciplinary Research in Colorectal Cancer Prognosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02328677
Enrollment
5000
Registered
2014-12-31
Start date
2007-03-31
Completion date
2030-10-31
Last updated
2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Colorectal cancer, rectosigmoid, rectum, colon

Brief summary

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

Detailed 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.

Interventions

None listed

Sponsors

German Cancer Research Center
CollaboratorOTHER
H. Lee Moffitt Cancer Center and Research Institute
CollaboratorOTHER
Huntsman Cancer Institute
CollaboratorOTHER
Cedars-Sinai Medical Center
CollaboratorOTHER
Washington University School of Medicine
CollaboratorOTHER
University of Tennessee
CollaboratorOTHER
University of Utah
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

Inclusion criteria

1. Age 18-89 years; for patients recruited after 09/01/2021 the age range is 18-69 years. Recruitment of patients 70 years and older was maintained for specific sub-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 and HCI) 4. English (FHCRC, Moffitt, HCI, Cedars-Sinai, WashU St. Louis) or German (University Hospital Heidelberg)-speaking; 5. mentally/physically able to consent and participate.

Exclusion criteria

* if one of the above in not fulfilled * insufficient language or consent capacity

Design outcomes

Primary

MeasureTime frame
Disease-free and overall survivalup to 10 years
Recurrenceup to 5 years

Secondary

MeasureTime frame
Health-related quality of lifeat 0, 3, 6, 12, 24, 36, 48, 60 months post recruitment
Treatment toxicitiesup to 5 years post treatment

Countries

Germany, United States

Contacts

Primary ContactCornelia Ulrich, MS, PhD
neli.ulrich@hci.utah.edu(801) 213-5716
Backup ContactSheetal Hardikar, PhD
sheetal.hardikar@hci.utah.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026