ColoCare Study - Colorectal Cancer Cohort

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

Detailed Description
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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.

Official Title
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ColoCare Transdisciplinary Research in Colorectal Cancer Prognosis

Conditions
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Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ColoCare FHCRC<br>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 | |
| ColoCare Moffitt (affiliated cohort)<br>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 | |
| University Hospital Heidelberg<br>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 | |
| ColoCare Huntsman Cancer Institute<br>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 | |
| Cedars-Sinai Medical Center<br>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 | |
| Washington University School of Medicine in St. Louis<br>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 | |
| University of Tennessee<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free and overall survival |  | up to 10 years | 
| Recurrence |  | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life |  | at 0, 3, 6, 12, 24, 36, 48, 60 months post recruitment | 
| Treatment toxicities |  | up to 5 years post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, rectosigmoid, rectum, colon