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NCT Number: NCT02328677

ColoCare Study - Colorectal Cancer Cohort

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

Recruiting

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Heidelberg, Heidelberg, Baden-Wurttemberg, Germany

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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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • mentally/physically able to consent and participate.

Exclusion criteria

  • if one of the above in not fulfilled
  • insufficient language or consent capacity

Treatment and study plan

Primary outcomes

  1. Disease-free and overall survival

    Time frame: up to 10 years

  2. Recurrence

    Time frame: up to 5 years

Secondary outcomes

  1. Health-related quality of life

    Time frame: at 0, 3, 6, 12, 24, 36, 48, 60 months post recruitment

  2. Treatment toxicities

    Time frame: up to 5 years post treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Cornelia Ulrich, MS, PhD

CONTACT

[email protected]

(801) 213-5716

Sheetal Hardikar, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Cedars-Sinai Medical Center
  • German Cancer Research Center
  • H. Lee Moffitt Cancer Center and Research Institute
  • Huntsman Cancer Institute
  • University of Tennessee
  • Washington University School of Medicine

Registry information

Official study title

ColoCare Transdisciplinary Research in Colorectal Cancer Prognosis

Important dates

Study start
2007
Primary completion
2030
Study completion
2030
First posted
Dec 31, 2014
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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