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Clinical Trials/NCT02243267
NCT02243267
Completed
N/A

Biospecimens for the Diagnosis, Treatment and Prevention of Colorectal Cancer

University of Michigan1 site in 1 country115 target enrollmentSeptember 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Colon Cancer
Sponsor
University of Michigan
Enrollment
115
Locations
1
Primary Endpoint
New Biomarker for colon cancer detection
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The investigators are creating a data and specimen repository to study causes , early detection, prevention and treatment of colon and rectal cancer. The investigators are collecting data and specimens (blood, stool, urine and tissue) from people who have colon or rectal cancer, or who are risk for developing colorectal cancer or had normal colonoscopies. Data and samples are held in the repository until there are enough to be used for a large study or until there are new techniques that can be used to test them. The GI SPORE Program at the University of Michigan maintains a repository of specimens for colorectal diseases that the investigators hope will help fuel new research. The investigators hope that this work may lead to new treatments or earlier detection of colorectal cancer or improved diagnosis and treatment of other colon and rectal diseases.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
August 31, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Missy Tuck

Project manager

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • 5.2 General Eligibility Criteria 5.2.1 Overall Inclusion
  • Adults 18 years of age or older
  • Willing to sign informed consent.
  • Able to tolerate removal of up to 50 ml of blood
  • 5.2.2 Overall Exclusion Criteria
  • Pregnant, lactating
  • Unable to understand English
  • Known HIV/AIDS or Hepatitis C
  • 5.3 Disease or Control Specific Eligibility Criteria 5.3.1 Unaffected Healthy Individuals (Healthy Controls)
  • No prior colorectal neoplasia

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

New Biomarker for colon cancer detection

Time Frame: 6 years

To create a longitudinal biorepository from individuals with colorectal cancer, those who are high risk for developing colorectal cancer, and screened, endoscopically normal controls including a reference set of well annotated, pathologically confirmed tissue, plasma, serum, and white blood cell biosamples and corresponding demographic, risk, and clinical treatment data for improved colon cancer detection.

Response to Treatment

Time Frame: 6 years

To create a longitudinal biorepository from individuals with colorectal cancer, those who are high risk for developing colorectal cancer, and screened, endoscopically normal controls including a reference set of well annotated, pathologically confirmed tissue, plasma, serum, and white blood cell biosamples and corresponding demographic, risk, and clinical treatment data for improved colon cancer detection.

Study Sites (1)

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