Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2026-01-24 @ 11:47 PM
Study NCT ID:
NCT00625066
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2008-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological, Genetic, and Lifestyle Risk Factors for Developing Colorectal Adenomas or Polyps in Participants Undergoing Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2008-02-27', 'studyFirstSubmitQcDate': '2008-02-27', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment of 7,000 participants who are planning to undergo colonoscopy'}, {'measure': 'Collection of questionnaires and medical records'}, {'measure': 'Collection of biological samples, including urine, blood, buccal cells and/or saliva, rectal tissue, and colorectal polyps'}, {'measure': 'Evaluation of risk factors and other differences between participants found to have polyps and those who do not have polyps'}]}, 'conditionsModule': {'keywords': ['precancerous condition', 'colon cancer', 'rectal cancer'], 'conditions': ['Colorectal Cancer', 'Precancerous Condition']}, 'referencesModule': {'references': [{'pmid': '22277551', 'type': 'DERIVED', 'citation': 'Murff HJ, Shrubsole MJ, Cai Q, Smalley WE, Dai Q, Milne GL, Ness RM, Zheng W. Dietary intake of PUFAs and colorectal polyp risk. Am J Clin Nutr. 2012 Mar;95(3):703-12. doi: 10.3945/ajcn.111.024000. Epub 2012 Jan 25.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: This clinical trial is looking at biological, genetic, and lifestyle risk factors for developing colorectal adenomas or polyps in participants undergoing colonoscopy.', 'detailedDescription': "OBJECTIVES:\n\n* To recruit 7,000 participants who are planning to undergo colonoscopy.\n* To collect questionnaires and medical records from these participants.\n* To collect biological samples, including urine, blood, buccal cells and/or saliva, rectal tissue, and colorectal polyps from these participants.\n* To evaluate risk factors and other differences between participants found to have polyps and those who do not have polyps.\n\nOUTLINE: Participants undergo screening colonoscopy and removal of any polyps.\n\nWithin 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.\n\nBlood 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.\n\nTissue samples may be stored for future genetic studies to evaluate genetic factors that may cause or be related to colon polyps or colorectal cancer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'participants who are planning to undergo colonoscopy', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Scheduled to undergo colonoscopy at the Vanderbilt University Medical Center or the Tennessee Valley Veterans Administration Medical Center\n* No prior genetic colorectal cancer syndromes or colorectal adenoma\n\nPATIENT CHARACTERISTICS:\n\n* Must have a permanent residence and a telephone number\n* Able to speak and understand English\n* No prior inflammatory bowel disease\n* No prior cancer other than nonmelanoma skin cancer\n* Not a current resident in a correctional facility\n* 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)\n* No prior extensive knowledge or contact with the investigation/protocol/hypotheses (the study collaborator or reviewer)\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior partial or complete colon resection\n* No concurrent participation in a clinical trial involving the prevention of colon polyps'}, 'identificationModule': {'nctId': 'NCT00625066', 'briefTitle': 'Biological, Genetic, and Lifestyle Risk Factors for Developing Colorectal Adenomas or Polyps in Participants Undergoing Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Tennessee Colorectal Polyp Study', 'orgStudyIdInfo': {'id': 'CDR0000583154'}, 'secondaryIdInfos': [{'id': 'P30CA068485', 'link': 'https://reporter.nih.gov/quickSearch/P30CA068485', 'type': 'NIH'}, {'id': 'VU-VICC-GI-0294'}, {'id': 'VU-VICC-020603'}, {'id': 'VU-VICC-020531'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'biologic sample preservation procedure', 'type': 'OTHER'}, {'name': 'cytology specimen collection procedure', 'type': 'OTHER'}, {'name': 'medical chart review', 'type': 'OTHER'}, {'name': 'questionnaire administration', 'type': 'OTHER'}, {'name': 'survey administration', 'type': 'OTHER'}, {'name': 'biopsy', 'type': 'PROCEDURE'}, {'name': 'evaluation of cancer risk factors', 'type': 'PROCEDURE'}, {'name': 'screening colonoscopy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37064', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center - Cool Springs', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37064', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center at Franklin', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Nashville', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232-6838', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Wei Zheng, MD, PhD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Wei Zheng', 'investigatorAffiliation': 'Vanderbilt University'}}}}