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

NCT00625066 | Completed

• 5 other identifiers: CDR0000583154P30CA068485VU-VICC-GI-0294VU-VICC-020603VU-VICC-020531
• Study Type: observational
• Target: 8,108
• Locations: 1 country
• Sites: 4

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.

Conditions

Colorectal Cancer; Precancerous Condition

Keywords

precancerous condition; colon cancer; rectal cancer

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

biologic sample preservation procedure OTHER

cytology specimen collection procedure OTHER

medical chart review OTHER

questionnaire administration OTHER

survey administration OTHER

biopsy PROCEDURE

evaluation of cancer risk factors PROCEDURE

screening colonoscopy PROCEDURE

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

participants who are planning to undergo colonoscopy

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Veterans Affairs Medical Center - Nashville

Nashville, Tennessee, 37212, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related Publications (1)

• 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.

  PMID: 22277551 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Precancerous Conditions; Colonic Neoplasms; Rectal Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Wei Zheng, MD, PhD, MPH

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: February 28, 2008
• Study Start: January 1, 2003
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (4)