Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-01 @ 6:10 AM
Study NCT ID:
NCT02876133
Status:
UNKNOWN
Last Update Posted:
2018-09-26
First Post:
2016-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Narrow Band Imaging Versus White Light for Colonoscopy Serrate Lesions Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D011127', 'term': 'Polyps'}], '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': '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': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 987}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-25', 'studyFirstSubmitDate': '2016-08-18', 'studyFirstSubmitQcDate': '2016-08-18', 'lastUpdatePostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'average number of serrated lesions ≥10 mm detected per colonoscopy', 'timeFrame': 'immediate'}], 'secondaryOutcomes': [{'measure': 'Serrated class lesions detection rate', 'timeFrame': 'immediate', 'description': 'number of patients with at least 1 lesion/total number of participants'}, {'measure': 'Serrated lesions <10 mm detected per colonoscopy', 'timeFrame': 'immediate'}, {'measure': 'SSL detection rate', 'timeFrame': 'immediate', 'description': 'histologically defined according to the WHO criteria'}, {'measure': 'Adenoma detection rate', 'timeFrame': 'immediate', 'description': 'number of patients with at least 1 adenoma/total number of participants'}, {'measure': 'Adenomas detected per colonoscopy', 'timeFrame': 'immediate'}, {'measure': 'Advanced (malignant) adenocarcinoma detection rate', 'timeFrame': 'immediate'}, {'measure': 'Incidence of procedure related adverse events', 'timeFrame': 'immediate'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colon Cancer', 'Colon Sessile Serrated Adenoma/Polyp']}, 'referencesModule': {'references': [{'pmid': '22710576', 'type': 'BACKGROUND', 'citation': "Rex DK, Ahnen DJ, Baron JA, Batts KP, Burke CA, Burt RW, Goldblum JR, Guillem JG, Kahi CJ, Kalady MF, O'Brien MJ, Odze RD, Ogino S, Parry S, Snover DC, Torlakovic EE, Wise PE, Young J, Church J. Serrated lesions of the colorectum: review and recommendations from an expert panel. Am J Gastroenterol. 2012 Sep;107(9):1315-29; quiz 1314, 1330. doi: 10.1038/ajg.2012.161. Epub 2012 Jun 19."}]}, 'descriptionModule': {'briefSummary': "Colorectal cancer (CRC) is a leading cause of cancer death and its' incidence is rising in most European countries. Colonoscopy has been shown to reduce CRC incidence, however its effectiveness depends on the sensitivity to detect pre-malignant lesions.\n\nOur aim is to evaluate narrow band imaging (NBI) during colonoscopy and serum miRNAs as novel tools for the early detection of colonic sessile serrated lesions (SSL). The investigators will perform a multicenter-randomized-controlled-trial to study the role of NBI in SSL detection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective colonoscopies\n\nExclusion Criteria:\n\n* known polyposis syndromes\n* primary sclerosing cholangitis\n* inflammatory bowel disease\n* personal colorectal cancer history'}, 'identificationModule': {'nctId': 'NCT02876133', 'briefTitle': 'Narrow Band Imaging Versus White Light for Colonoscopy Serrate Lesions Detection', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Beatriz Ângelo'}, 'officialTitle': 'Improving Colorectal Cancer Screening: Using Narrow Band Imaging for Colonic Sessile Serrated Lesions', 'orgStudyIdInfo': {'id': '176'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Narrow band imaging withdrawal', 'description': 'colonoscope withdrawal and mucosal inspection performed under narrow band imaging', 'interventionNames': ['Device: narrow band imaging withdrawal']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'white light withdrawal', 'description': 'colonoscope withdrawal and mucosal inspection performed under white light imaging', 'interventionNames': ['Device: white light withdrawal']}], 'interventions': [{'name': 'narrow band imaging withdrawal', 'type': 'DEVICE', 'description': 'colonoscope withdrawal and mucosal inspection performed under narrow band imaging', 'armGroupLabels': ['Narrow band imaging withdrawal']}, {'name': 'white light withdrawal', 'type': 'DEVICE', 'description': 'colonoscope withdrawal and mucosal inspection performed under white light imaging', 'armGroupLabels': ['white light withdrawal']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Loures', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Alexandre O Ferreira, MD', 'role': 'CONTACT', 'email': 'alex.gastrohep@gmail.com'}, {'name': 'Alexandre O Ferreira, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Beatriz Ângelo', 'geoPoint': {'lat': 38.83091, 'lon': -9.16845}}, {'city': 'Porto', 'status': 'NOT_YET_RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Ricardo M Pinto, MD, PhD', 'role': 'CONTACT', 'email': 'ricardomarcospinto@sapo.pt'}, {'name': 'Ricardo M Pinto, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro Hospitalar do Porto', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'city': 'Porto', 'status': 'NOT_YET_RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Mario D Ribeiro, MD, PhD', 'role': 'CONTACT', 'email': 'mdinisribeiro@gmail.com'}, {'name': 'Diogo Libânio, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instituto Português de Oncologia do Porto', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'centralContacts': [{'name': 'Alexandre O Ferreira, MD', 'role': 'CONTACT', 'email': 'alex.gastrohep@gmail.com'}], 'overallOfficials': [{'name': 'Alexandre O Ferreira, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Beatriz Ângelo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Beatriz Ângelo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gastroenterologist', 'investigatorFullName': 'Alexandre Ferreira', 'investigatorAffiliation': 'Hospital Beatriz Ângelo'}}}}