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ColoCare Study - Colorectal Cancer Cohort

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ClinicalTrials.gov Identifier: NCT02328677
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Cornelia Ulrich, University of Utah

Tracking Information
First Submitted Date November 17, 2014
First Posted Date December 31, 2014
Last Update Posted Date October 19, 2020
Study Start Date March 2007
Estimated Primary Completion Date October 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 29, 2014)
  • Disease-free and overall survival [ Time Frame: up to 10 years ]
  • Recurrence [ Time Frame: up to 5 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 29, 2014)
  • Health-related quality of life [ Time Frame: at 0, 3, 6, 12, 24, 36, 48, 60 months post recruitment ]
  • Treatment toxicities [ Time Frame: up to 5 years post treatment ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ColoCare Study - Colorectal Cancer Cohort
Official Title ColoCare Transdisciplinary Research in Colorectal Cancer Prognosis
Brief Summary ColoCare is an international prospective cohort study of stage I-IV colorectal cancer patients (ICD-10 C18-C20).
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 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood, urine, feces, saliva, FFPE and fresh frozen tissue (multiple sources/locations) from the tumor, DNA, RNA, miRNA, visceral adipose tissue and subcutaneous adipose tissue.
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.
Condition Colorectal Cancer
Intervention Not Provided
Study Groups/Cohorts
  • 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 April 30, 2020: n=611
  • 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 April 30, 2020: n=835
  • 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 April 30, 2020: n=683
  • 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 April 30, 2020: n=294
  • 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 April 30, 2020: n=203
  • University of Washington 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 April 30, 2020: n=195
  • 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 April 30, 2020: n=153
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 29, 2014)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2030
Estimated Primary Completion Date October 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Age 18-89 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-Senai, UW St. Louis, UT) 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Cornelia Ulrich, MS, PhD (801) 213-5716 neli.ulrich@hci.utah.edu
Contact: Erin Siegel, MD 813-745-6533 erin.siegel@moffitt.org
Listed Location Countries Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02328677
Other Study ID Numbers 6407
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Cornelia Ulrich, University of Utah
Study Sponsor University of Utah
Collaborators
  • 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
Investigators
Principal Investigator: Cornelia M Ulrich, MS, PhD Huntsman Cancer Institute
Principal Investigator: William Grady, MD, PhD Fred Hutchinson Cancer Research Center
Principal Investigator: Martin Schneider, MD University Hospital Heidelberg
Principal Investigator: Christopher Li, MD Fred Hutchinson Cancer Research Center
Principal Investigator: Erin Siegel, PhD Lee H. Moffitt Cancer Center
Principal Investigator: Jane Figueireido, PhD Cedars-Senai Medical Center
Principal Investigator: David Shibata, MD University of Tennesee
Principal Investigator: Adetunji T. Toriola, MD, PhD University of Washington St. Louis
PRS Account University of Utah
Verification Date October 2020