Clinical trial NCT00625066: Biological, Genetic, and Lifestyle Risk Factors for Developing Colorectal Adenomas or Polyps in Participants Undergoing Colonoscopy
Official title: Tennessee Colorectal Polyp Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer
Precancerous Condition
Keywords: precancerous condition
colon cancer
rectal cancer
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-02-28
Enrollment: 8108
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: participants who are planning to undergo colonoscopy

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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Recruitment of 7,000 participants who are planning to undergo colonoscopy
measure: Collection of questionnaires and medical records
measure: Collection of biological samples, including urine, blood, buccal cells and/or saliva, rectal tissue, and colorectal polyps
measure: Evaluation of risk factors and other differences between participants found to have polyps and those who do not have polyps
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Nashville
country: United States
facility: Veterans Affairs Medical Center - Nashville
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Wei Zheng, MD, PhD, MPH
role: STUDY_CHAIR
References:
citation: 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.