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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00625066
First received: February 27, 2008
Last updated: January 27, 2010
Last verified: October 2008
  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
Official Title: Tennessee Colorectal Polyp Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Recruitment of 7,000 participants who are planning to undergo colonoscopy [ Designated as safety issue: No ]
  • Collection of questionnaires and medical records [ Designated as safety issue: No ]
  • Collection of biological samples, including urine, blood, buccal cells and/or saliva, rectal tissue, and colorectal polyps [ Designated as safety issue: No ]
  • Evaluation of risk factors and other differences between participants found to have polyps and those who do not have polyps [ Designated as safety issue: No ]

Estimated Enrollment: 7000
Study Start Date: January 2003
Estimated 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

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625066

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
Vanderbilt-Ingram Cancer Center - Cool Springs Recruiting
Nashville, Tennessee, United States, 37064
Contact: Wei Zheng    615-936-0682      
Vanderbilt-Ingram Cancer Center at Franklin Recruiting
Nashville, Tennessee, United States, 37064
Contact: Wei Zheng    615-936-0682      
Veterans Affairs Medical Center - Nashville Recruiting
Nashville, Tennessee, United States, 37212
Contact: Clinical Trials Office - Veterans Affairs Medical Center - Nas    615-327-4751      
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: Wei Zheng, MD, PhD, MPH Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00625066     History of Changes
Other Study ID Numbers: CDR0000583154, VU-VICC-GI-0294, VU-VICC-020603, VU-VICC-020531
Study First Received: February 27, 2008
Last Updated: January 27, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
precancerous condition
colon cancer
rectal cancer

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

ClinicalTrials.gov processed this record on November 24, 2014