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Biological, Genetic, and Lifestyle Risk Factors for Developing Colorectal Adenomas or Polyps in Participants Undergoing Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00625066
Recruitment Status : Active, not recruiting
First Posted : February 28, 2008
Last Update Posted : January 17, 2019
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wei Zheng, Vanderbilt University

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 learn more about cancer risk factors.

PURPOSE: This clinical trial is looking at biological, genetic, and lifestyle risk factors for developing colorectal adenomas or polyps in participants undergoing colonoscopy.

Condition or disease Intervention/treatment
Colorectal Cancer Precancerous Condition Other: biologic sample preservation procedure Other: cytology specimen collection procedure Other: medical chart review Other: questionnaire administration Other: survey administration Procedure: biopsy Procedure: evaluation of cancer risk factors Procedure: screening colonoscopy

Detailed Description:


  • 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.

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Study Type : Observational
Actual Enrollment : 8108 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tennessee Colorectal Polyp Study
Study Start Date : January 2003
Actual Primary Completion Date : January 2011
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Primary Outcome Measures :
  1. Recruitment of 7,000 participants who are planning to undergo colonoscopy
  2. Collection of questionnaires and medical records
  3. Collection of biological samples, including urine, blood, buccal cells and/or saliva, rectal tissue, and colorectal polyps
  4. Evaluation of risk factors and other differences between participants found to have polyps and those who do not have polyps

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
participants who are planning to undergo colonoscopy


  • 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


  • 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)


  • No prior partial or complete colon resection
  • No concurrent participation in a clinical trial involving the prevention of colon polyps

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00625066

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United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, United States, 37212
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
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Study Chair: Wei Zheng, MD, PhD, MPH Vanderbilt-Ingram Cancer Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Wei Zheng, Professor, Vanderbilt University Identifier: NCT00625066    
Other Study ID Numbers: CDR0000583154
P30CA068485 ( U.S. NIH Grant/Contract )
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Keywords provided by Wei Zheng, Vanderbilt University:
precancerous condition
colon cancer
rectal cancer
Additional relevant MeSH terms:
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Precancerous Conditions