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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer; Precancerous Condition
• Intervention / Treatment: Other: biologic sample preservation procedure; Other: medical chart review; Other: survey administration; Procedure: screening colonoscopy; Other: questionnaire administration; Procedure: biopsy; Procedure: evaluation of cancer risk factors; Other: cytology specimen collection procedure

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.

• Study Type: Observational
• Enrollment (Actual): 8108

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232-6838
      • Vanderbilt-Ingram Cancer Center
    • Nashville, Tennessee, United States, 37212
      • Veterans Affairs Medical Center - Nashville
    • Nashville, Tennessee, United States, 37064
      • Vanderbilt-Ingram Cancer Center - Cool Springs
    • Nashville, Tennessee, United States, 37064
      • Vanderbilt-Ingram Cancer Center at Franklin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

participants who are planning to undergo colonoscopy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Wei Zheng, MD, PhD, MPH, Vanderbilt-Ingram Cancer Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2003
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: February 27, 2008
• First Submitted That Met QC Criteria: February 27, 2008
• First Posted (Estimated): February 28, 2008

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: rectal cancer; colon cancer; precancerous condition
• Additional Relevant MeSH Terms: Neoplasms; Precancerous Conditions
• Other Study ID Numbers: CDR0000583154; P30CA068485 (U.S. NIH Grant/Contract); VU-VICC-GI-0294; VU-VICC-020603; VU-VICC-020531