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Tennessee Colorectal Polyp Study


N/A
40 Years
75 Years
Open (Enrolling)
Both
Colorectal Cancer, Precancerous Condition

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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 CenterNashville, Tennessee  37232-6838
Veterans Affairs Medical Center - NashvilleNashville, Tennessee  37212
Vanderbilt-Ingram Cancer Center - Cool SpringsNashville, Tennessee  37064
Vanderbilt-Ingram Cancer Center at FranklinNashville, Tennessee  37064