Tennessee Colorectal Polyp Study
40 Years
75 Years
Both
Colorectal Cancer, Precancerous Condition
Trial Information
Tennessee Colorectal Polyp Study
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.
Inclusion Criteria
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
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Recruitment of 7,000 participants who are planning to undergo colonoscopy
Safety Issue:
No
Principal Investigator
Wei Zheng, MD, PhD, MPH
Investigator Role:
Study Chair
Investigator Affiliation:
Vanderbilt-Ingram Cancer Center
Authority:
Unspecified
Study ID:
CDR0000583154
NCT ID:
NCT00625066
Start Date:
January 2003
Completion Date:
Related Keywords:
- Colorectal Cancer
- Precancerous Condition
- precancerous condition
- colon cancer
- rectal cancer
- Colorectal Neoplasms
- Precancerous Conditions
Name | Location |
|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Veterans Affairs Medical Center - Nashville | Nashville, Tennessee 37212 |
| Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville, Tennessee 37064 |
| Vanderbilt-Ingram Cancer Center at Franklin | Nashville, Tennessee 37064 |
