ColoCare Study - Colorectal Cancer Cohort

Colorectal Cancer Clinical Trial

Official title: ColoCare Transdisciplinary Research in Colorectal Cancer Prognosis

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT02328677
• Study type: Observational
• Source: University of Utah
• Contact: Cornelia Ulrich, MS, PhD
• Phone: (801) 213-5716
• Email: neli.ulrich@hci.utah.edu
• Status: Recruiting
• Start date: March 2007
• Completion date: October 2030