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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00625066
First Posted: February 28, 2008
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wei Zheng, Vanderbilt University
  Purpose

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.


Condition Intervention
Colorectal Cancer Precancerous Condition Other: biologic sample preservation procedure Other: cytology specimen collection procedure Other: medical chart review Other: questionnaire administration Other: survey administration Procedure: biopsy Procedure: evaluation of cancer risk factors Procedure: screening colonoscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tennessee Colorectal Polyp Study

Resource links provided by NLM:


Further study details as provided by Wei Zheng, Vanderbilt University:

Primary Outcome Measures:
  • 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

Enrollment: 8108
Study Start Date: January 2003
Estimated Study Completion Date: October 2025
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
participants who are planning to undergo colonoscopy
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625066


Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, United States, 37212
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
Investigators
Study Chair: Wei Zheng, MD, PhD, MPH Vanderbilt-Ingram Cancer Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wei Zheng, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00625066     History of Changes
Other Study ID Numbers: CDR0000583154
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-GI-0294
VU-VICC-020603
VU-VICC-020531
First Submitted: February 27, 2008
First Posted: February 28, 2008
Last Update Posted: October 17, 2017
Last Verified: October 2017

Keywords provided by Wei Zheng, Vanderbilt University:
precancerous condition
colon cancer
rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Precancerous Conditions
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases