RecruitingRecruiting
ColoCare Study - Colorectal Cancer Cohort
NCT02328677 · University of Utah
In plain English
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Official title
ColoCare Transdisciplinary Research in Colorectal Cancer Prognosis
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 5000 participants
Age groups: adult, older_adult
Timeline
Starts: 2007-03
Estimated completion: 2030-10
Last updated: 2025-06-13
Primary outcomes
- • Disease-free and overall survival (up to 10 years)
- • Recurrence (up to 5 years)
Sponsor
University of Utah · other
With: German Cancer Research Center, H. Lee Moffitt Cancer Center and Research Institute, Huntsman Cancer Institute, Cedars-Sinai Medical Center, Washington University School of Medicine, University of Tennessee
Contacts & investigators
ContactCornelia Ulrich, MS, PhD · contact · neli.ulrich@hci.utah.edu · (801) 213-5716
ContactSheetal Hardikar, PhD · contact · sheetal.hardikar@hci.utah.edu
InvestigatorCornelia M Ulrich, MS, PhD · principal_investigator, Huntsman Cancer Institute
InvestigatorWilliam Grady, MD, PhD · principal_investigator, Fred Hutchinson Cancer Center
InvestigatorChristopher Li, MD · principal_investigator, Fred Hutchinson Cancer Center
All locations (7)
Cedars-Sinai Medical CenterRecruiting
Los Angeles, California, United States
Lee H. Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
University of TennesseeRecruiting
Knoxville, Tennessee, United States
Huntsman Cancer InstituteRecruiting
Salt Lake City, Utah, United States
FHCRCRecruiting
Seattle, Washington, United States
University Hospital HeidelbergRecruiting
Heidelberg, Baden-Wurttemberg, Germany