Status:
COMPLETED
Biological, Genetic, and Lifestyle Risk Factors for Developing Colorectal Adenomas or Polyps in Participants Undergoing Colonoscopy
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Precancerous Condition
Eligibility:
All Genders
40-75 years
Brief Summary
RATIONALE: Collecting and storing samples of tissue, blood, and other body fluids to test in the laboratory and gathering information about health and lifestyle from participants may help doctors lear...
Detailed Description
OBJECTIVES: * To recruit 7,000 participants who are planning to undergo colonoscopy. * To collect questionnaires and medical records from these participants. * To collect biological samples, includin...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Scheduled to undergo colonoscopy at the Vanderbilt University Medical Center or the Tennessee Valley Veterans Administration Medical Center
- No prior genetic colorectal cancer syndromes or colorectal adenoma
- PATIENT CHARACTERISTICS:
- Must have a permanent residence and a telephone number
- Able to speak and understand English
- No prior inflammatory bowel disease
- No prior cancer other than nonmelanoma skin cancer
- Not a current resident in a correctional facility
- No other rare exclusion that would prevent the collection of study data (e.g., extensive memory loss for past exposures), impair ability to provide informed consent, or make the participant an atypical colonoscopy patient (e.g., colonoscopy for organ transplant evaluation)
- No prior extensive knowledge or contact with the investigation/protocol/hypotheses (the study collaborator or reviewer)
- PRIOR CONCURRENT THERAPY:
- No prior partial or complete colon resection
- No concurrent participation in a clinical trial involving the prevention of colon polyps
Exclusion
Key Trial Info
Start Date :
January 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2025
Estimated Enrollment :
8108 Patients enrolled
Trial Details
Trial ID
NCT00625066
Start Date
January 1 2003
End Date
November 30 2025
Last Update
December 17 2025
Active Locations (4)
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1
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
2
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
3
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, United States, 37212
4
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838