Recruiting

ColoCare Transdisciplinary Research in Colorectal Cancer Prognosis

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What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Colonic Diseases+8

+ Digestive System Diseases

+ Digestive System Neoplasms

From 18 to 89 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 2007
See protocol details

Summary

Principal SponsorUniversity of Utah
Study ContactCornelia Ulrich, MS, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2007

Actual date on which the first participant was enrolled.

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.

Official TitleColoCare Transdisciplinary Research in Colorectal Cancer Prognosis
Principal SponsorUniversity of Utah
Study ContactCornelia Ulrich, MS, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

5000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 89 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal Neoplasms

Criteria

5 inclusion criteria required to participate
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

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;

Show More Criteria

2 exclusion criteria prevent from participating
if one of the above in not fulfilled

insufficient language or consent capacity

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Recruiting

Cedars-Sinai Medical Center

Los Angeles, United StatesOpen Cedars-Sinai Medical Center in Google Maps
Recruiting

Lee H. Moffitt Cancer Center

Tampa, United States
Recruiting

Washington University School of Medicine

St Louis, United States
Recruiting

University of Tennessee

Knoxville, United States
Recruiting
7 Study Centers