ColoCare Study - Colorectal Cancer Cohort

May 22, 2022 updated by: Cornelia Ulrich, University of Utah

ColoCare Transdisciplinary Research in Colorectal Cancer Prognosis

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

Study Overview

Status

Recruiting

Conditions

Detailed Description

The ColoCare Consortium 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 Research 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 pilot studies.

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 (young 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.

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:
    • Florida
      • Tampa, Florida, United States, 12902
    • Missouri
      • Saint Louis, Missouri, United States, 63112
        • Recruiting
        • Washington University School of Medicine
        • Contact:
    • Tennessee
      • Knoxville, Tennessee, United States, 37996
    • Utah
      • Salt Lake City, Utah, United States, 84112
    • Washington
      • Seattle, Washington, United States, 98109-1024

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ColoCare is an international prospective cohort study of stage I-IV colorectal cancer patients (ICD-10 C18-C20). The ColoCare Consortium is a multicenter initiative of interdisciplinary research on CRC outcome and prognosis, and comprises patient recruitment at 6 sites. Patients are recruited at baseline (time of first diagnosis, time prior to surgery or during treatment (FHCRC and HCI)) and followed for up to 10 years at regular timepoints (3m, 6m, 12m, 24m, 36m, 48m, 60m). The cohort includes a comprehensive collection of biospecimens and data.

Description

Inclusion Criteria:

  1. Age 18-89 years; for patients recruited after 09/01/2021 the age range is 18-69 years
  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 Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ColoCare FHCRC
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, 2021: n=679
ColoCare Moffitt (affiliated cohort)
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, 2021: n=895
University Hospital Heidelberg
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, 2021: n=721
ColoCare Huntsman Cancer Institute
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, 2021: n=394
Cedars-Sinai Medical Center
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, 2021: n=234
Washington University School of Medicine in St. Louis
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, 2021: n=232
University of Tennessee
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, 2021: n=183

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free and overall survival
Time Frame: up to 10 years
up to 10 years
Recurrence
Time Frame: up to 5 years
up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Health-related quality of life
Time Frame: at 0, 3, 6, 12, 24, 36, 48, 60 months post recruitment
at 0, 3, 6, 12, 24, 36, 48, 60 months post recruitment
Treatment toxicities
Time Frame: up to 5 years post treatment
up to 5 years post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Cornelia M Ulrich, MS, PhD, Huntsman Cancer Institute
  • Principal Investigator: William Grady, MD, PhD, Fred Hutchinson Cancer Center
  • Principal Investigator: Martin Schneider, MD, University Hospital Heidelberg
  • Principal Investigator: Christopher Li, MD, Fred Hutchinson Cancer Center
  • Principal Investigator: Erin Siegel, PhD, Lee H. Moffitt Cancer Center
  • Principal Investigator: Jane Figueiredo, PhD, Cedars-Sinai Medical Center
  • Principal Investigator: David Shibata, MD, University of Tennesee
  • Principal Investigator: Adetunji T. Toriola, MD, PhD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Anticipated)

October 1, 2030

Study Completion (Anticipated)

October 1, 2030

Study Registration Dates

First Submitted

November 17, 2014

First Submitted That Met QC Criteria

December 29, 2014

First Posted (Estimate)

December 31, 2014

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 22, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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