Biological, Genetic, & Lifestyle Risk Factors for Developing Colorectal

Status Active, not recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00625066
Study type	Observational
Source	Vanderbilt University Medical Center
Contact
Status	Active, not recruiting
Phase
Start date	January 1, 2003
Completion date	October 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms