Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT00892593
Status:
UNKNOWN
Last Update Posted:
2014-07-21
First Post:
2009-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D000236', 'term': 'Adenoma'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-18', 'studyFirstSubmitDate': '2009-05-01', 'studyFirstSubmitQcDate': '2009-05-01', 'lastUpdatePostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of significant colon neoplasia among those who enter a screening or surveillance program with FIT testing added at yearly intervals vs. that of "usual care" patients in the same patient population.', 'timeFrame': 'yearly'}], 'secondaryOutcomes': [{'measure': 'the pathology found at repeat colonoscopy in each group.', 'timeFrame': 'Yearly'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colon', 'neoplasia', 'polyp', 'adenoma', 'FIT', 'cancer'], 'conditions': ['Colon Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.novanthealth.org/forsyth-medical-center/services/clinical-research.aspx', 'label': 'NovantHealthClinicalResearch/ASC-FIT'}]}, 'descriptionModule': {'briefSummary': 'The study will determine if adding fecal immunochemical testing (FIT) at yearly intervals to a colonoscopy screening program will improve colon cancer detection rates.', 'detailedDescription': 'This study will evaluate the benefit of augmenting a compliant College of Gastroenterology colorectal cancer screening program with the addition of yearly FIT testing at two critical points in the current recommended follow up: 1. In patients found to have adenomatous polyps for the first time after colonoscopy, the addition of FIT in yearly intervals following index colonoscopy and 2. For subjects with "clean" colonoscopies (no polyps found), the addition of FIT at yearly intervals starting in year 6 and continuing to year 10 or subsequent colonoscopy. Current screening guidelines do not recommend the combination of colonoscopy and FOBT.\n\nTwo factors plague an effective colon cancer screening program: 1) a less than 100% sensitivity (95% ) for optical colonoscopy to detect colon cancer, and 2) Limitations of guaiac based stool testing: low sensitivity ( 5% in single use) for detection of colon cancer and the traditional gFOBT is cumbersome for patients to perform, impeding patient acceptance and adherence.\n\nFIT offers a FOBT with improved sensitivity (65% for invasive colon cancer) and improved specificity and better patient compliance. The addition of FIT after initial colonoscopy could be applied to a screening program and thereby salvage "missed" lesions by increased detection rates'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup I (positive colonoscopy)\n\n* 18 to 75 years of age\n* male or female\n* willing to provide written informed consent\n* In the event that the colonoscopy is incomplete, or polypectomy is partial, the above patients are eligible if a successful examination is completed within 6 months of the inadequate exam.\n\nGroup II (negative colonoscopy)\n\n* 50 to 69 years of age\n* Male or female\n* Willing to provide written informed consent\n* In the event that the colonoscopy is incomplete, the patient is eligible if a successful examination is completed within 6 months of the inadequate exam.\n\nExclusion Criteria:\n\nGroup I (positive colonoscopy)\n\n* chronic use of coumadin\n* history of previous GI malignancy, inflammatory bowel disease (Crohns disease, ulcerative colitis)\n* age or health status contraindicates repeat colonoscopy\n* history of Familial Polyposis or Hereditary Nonpolyposis Colon Cancer Syndrome\n* The index colonoscopy resulted in a perforation requiring surgical repair\n* An otherwise qualifying colonoscopy is followed by a recommendation for repeat colonoscopy in ≤ 1 yr.\n\nGroup II (negative colonoscopy)\n\n* chronic use of coumadin\n* history of previous GI malignancy, inflammatory bowel disease (Crohns disease, ulcerative colitis)\n* age or health status contraindicates repeat colonoscopy\n* history of Familial Polyposis or Hereditary Nonpolyposis Colon Cancer Syndrome\n* The index colonoscopy resulted in a perforation requiring surgical repair\n* Significant family history resulting in a recommendation for repeat colonoscopy in 5 years or less'}, 'identificationModule': {'nctId': 'NCT00892593', 'acronym': 'ASC-FIT', 'briefTitle': 'Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing', 'organization': {'class': 'OTHER', 'fullName': 'Forsyth Medical Center'}, 'officialTitle': 'Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing', 'orgStudyIdInfo': {'id': 'ASC-FIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 Fecal Immunochemical Testing-Surveillance', 'description': 'Fecal Immunochemical Testing performed at yearly intervals.', 'interventionNames': ['Device: Fecal Immunochemical Testing']}, {'type': 'NO_INTERVENTION', 'label': '2 Usual Care - Surveillance'}, {'type': 'NO_INTERVENTION', 'label': '3 Usual Care - Screening'}, {'type': 'EXPERIMENTAL', 'label': '4 Fecal Immunochemical Testing-Screening', 'description': 'Fecal Immunochemical Testing yearly, beginning at year 6.', 'interventionNames': ['Device: Fecal Immunochemical Testing']}], 'interventions': [{'name': 'Fecal Immunochemical Testing', 'type': 'DEVICE', 'otherNames': ['FIT'], 'description': 'Fecal Immunochemical Testing is a stool test specific for human hemoglobin.', 'armGroupLabels': ['1 Fecal Immunochemical Testing-Surveillance']}, {'name': 'Fecal Immunochemical Testing', 'type': 'DEVICE', 'otherNames': ['FIT'], 'description': 'Fecal Immunochemical Testing is a stool test specific for human hemoglobin.', 'armGroupLabels': ['4 Fecal Immunochemical Testing-Screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Digestive Health Specialists, PA', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erica Habersham', 'role': 'CONTACT', 'email': 'ehabersham@novanthealth.org', 'phone': '336-277-0203'}, {'name': 'Kyeshia Robinson', 'role': 'CONTACT', 'email': 'kyeshia.robinson@novanthealth.org', 'phone': '336.718-5813'}, {'name': 'Daniel Murphy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Piedmont Gastroenterology Specialists, PA', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erica Habersham', 'role': 'CONTACT', 'email': 'ehabersham@novanthealth.org', 'phone': '336-277-0203'}], 'facility': 'Salem Gastroenterology Associates, PA', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'centralContacts': [{'name': 'Debra W Norwood', 'role': 'CONTACT', 'email': 'dwnorwood@novanthealth.org', 'phone': '336-718-6045'}, {'name': 'Wendy L Hobbs', 'role': 'CONTACT', 'email': 'wlhobbs@novanthealth.org', 'phone': '336-718-5808'}], 'overallOfficials': [{'name': 'Daniel Murphy, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Piedmont Gastroenterology Specialists'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forsyth Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}