Biological, Genetic, and Lifestyle Risk Factors for Developing Colorectal Adenomas or Polyps in Participants Undergoing Colonoscopy
NCT ID: NCT00625066
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
8108 participants
OBSERVATIONAL
2003-01-01
2025-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This clinical trial is looking at biological, genetic, and lifestyle risk factors for developing colorectal adenomas or polyps in participants undergoing colonoscopy.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* To recruit 7,000 participants who are planning to undergo colonoscopy.
* To collect questionnaires and medical records from these participants.
* To collect biological samples, including urine, blood, buccal cells and/or saliva, rectal tissue, and colorectal polyps from these participants.
* To evaluate risk factors and other differences between participants found to have polyps and those who do not have polyps.
OUTLINE: Participants undergo screening colonoscopy and removal of any polyps.
Within 1 month of colonoscopy, participants undergo a 30-minute telephone interview and/or complete a mail survey to provide information on lifestyle and medical history that may be related to colorectal polyp risk. Participants who undergo removal of polyps during their colonoscopy also complete a 20-minute survey at their 3-year follow-up colonoscopy. Participants' medical records may also be reviewed.
Blood samples are collected at the time of colonoscopy. Some participants may also provide blood samples 1-2 weeks prior to colonoscopy. Tissue from the bisected portions of colorectal polyps \> 5 mm in size that are removed during colonoscopy is also obtained. Some participants may also undergo normal colorectal tissue sample and saliva sample collection at the time of colonoscopy and urine sample collection 2 days prior to, during, and/or 8 weeks after colonoscopy.
Tissue samples may be stored for future genetic studies to evaluate genetic factors that may cause or be related to colon polyps or colorectal cancer.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
biologic sample preservation procedure
cytology specimen collection procedure
medical chart review
questionnaire administration
survey administration
biopsy
evaluation of cancer risk factors
screening colonoscopy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
PRIOR CONCURRENT THERAPY:
* No prior partial or complete colon resection
* No concurrent participation in a clinical trial involving the prevention of colon polyps
40 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Vanderbilt University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Wei Zheng
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wei Zheng, MD, PhD, MPH
Role: STUDY_CHAIR
Vanderbilt-Ingram Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Murff HJ, Shrubsole MJ, Cai Q, Smalley WE, Dai Q, Milne GL, Ness RM, Zheng W. Dietary intake of PUFAs and colorectal polyp risk. Am J Clin Nutr. 2012 Mar;95(3):703-12. doi: 10.3945/ajcn.111.024000. Epub 2012 Jan 25.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VU-VICC-GI-0294
Identifier Type: -
Identifier Source: secondary_id
VU-VICC-020603
Identifier Type: -
Identifier Source: secondary_id
VU-VICC-020531
Identifier Type: -
Identifier Source: secondary_id
CDR0000583154
Identifier Type: -
Identifier Source: org_study_id