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

Colorectal Cancer Clinical Trial

Official title:

Tennessee Colorectal Polyp Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00625066
• Other study ID #: CDR0000583154
• Secondary ID: P30CA068485VU-VI
• Status: Active, not recruiting
• Start date: January 1, 2003
• Est. completion date: October 31, 2025

Study information

• Verified date: November 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8108
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Precancerous Condition
• Precancerous Conditions

Intervention

Other:
• biologic sample preservation procedure

• cytology specimen collection procedure

• medical chart review

• questionnaire administration

• survey administration

Procedure:
• biopsy

• evaluation of cancer risk factors

• screening colonoscopy

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment of 7,000 participants who are planning to undergo colonoscopy
Primary	Collection of questionnaires and medical records
Primary	Collection of biological samples, including urine, blood, buccal cells and/or saliva, rectal tissue, and colorectal polyps
Primary	Evaluation of risk factors and other differences between participants found to have polyps and those who do not have polyps