ColoCare Study - Colorectal Cancer Cohort

Recruiting

• Conditions: Colorectal Cancer

• Registration Number: NCT02328677
• Lead Sponsor: University of Utah

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). 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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-12-29
• Study First Posted: 2014-12-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20
• Primary Completion: 2030-10
• Study Completion: 2030-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence	up to 5 years
Disease-free and overall survival	up to 10 years

Secondary Outcome Measures

Name	Time	Method
Treatment toxicities	up to 5 years post treatment
Health-related quality of life	at 0, 3, 6, 12, 24, 36, 48, 60 months post recruitment

Trial Locations

Locations (7)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States

FHCRC; 🇺🇸 Seattle, Washington, United States

Lee H. Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

University of Tennessee; 🇺🇸 Knoxville, Tennessee, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

University Hospital Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany