Expired Study
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Nashville, Tennessee 37064


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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000583154


NCT ID:

NCT00625066


Secondary ID:

P30CA068485


Study Acronym:


Brief Title:

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


Official Title:

Tennessee Colorectal Polyp Study


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

40 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanderbilt University Medical Center


Oversight Authority:

Unspecified


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

8108


Enrollment Type:

Actual


Overall Contact Information

Official Name:Wei Zheng, MD, PhD, MPH
Study Chair
Vanderbilt-Ingram Cancer Center

Study Dates

Start Date:January 2003
Completion Date:October 2025
Completion Type:Anticipated
Primary Completion Date:January 2011
Primary Completion Type:Actual
Verification Date:January 2019
Last Changed Date:January 16, 2019
First Received Date:February 27, 2008

Study Outcomes

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

Study Interventions

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

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Vanderbilt University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Samples and Retentions

Study Population: participants who are planning to undergo colonoscopy
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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