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

Vanderbilt University8,108 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

8,108

Conditions

Colorectal Cancer Precancerous Condition

Interventions

biologic sample preservation procedureOTHER

cytology specimen collection procedureOTHER

medical chart reviewOTHER

questionnaire administration

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, United States

Veterans Affairs Medical Center - Nashville

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Recruitment of 7,000 participants who are planning to undergo colonoscopy

Collection of questionnaires and medical records

Collection of biological samples, including urine, blood, buccal cells and/or saliva, rectal tissue, and colorectal polyps

Evaluation of risk factors and other differences between participants found to have polyps and those who do not have polyps

Data from ClinicalTrials.gov

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