ColoCare Study - Colorectal Cancer Cohort

Utah System of Higher Education (USHE)

Status: Enrolling

Conditions: Colorectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02328677

6407

Details and patient eligibility

About

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

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

5,000 participants in 7 patient groups

ColoCare FHCC

Description:

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, 2023: n=741

ColoCare Moffitt (affiliated cohort)

Description:

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, 2023: n=1,043

University Hospital Heidelberg

Description:

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, 2023: n=773

ColoCare Huntsman Cancer Institute

Description:

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, 2023: n=514

Cedars-Sinai Medical Center

Description:

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, 2023: n=291

Washington University School of Medicine in St. Louis

Description:

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, 2023: n=278

University of Tennessee

Description:

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, 2023: n=253