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



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:40 - 75
Updated:1/19/2019
Start Date:January 2003
End Date:October 2025

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Tennessee Colorectal Polyp Study

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.

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, 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.

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
We found this trial at
4
sites
2107 Edward Curd Lane
Nashville, Tennessee 37067
615-591-9890
Vanderbilt-Ingram Cancer Center at Franklin The Vanderbilt-Ingram Cancer Center at Franklin is a free-standing radiation...
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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324 Cool Springs Blvd
Nashville, Tennessee 37067
(877) 936-8422
Vanderbilt-Ingram Cancer Center - Cool Springs Vanderbilt-Ingram Cancer Center Cool Springs is a medical oncology...
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Nashville, Tennessee 37212
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Nashville, TN
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