Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT02570516
Status:
COMPLETED
Last Update Posted:
2019-09-23
First Post:
2015-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003123', 'term': 'Colorectal Neoplasms, Hereditary Nonpolyposis'}], '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': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003113', 'term': 'Colonoscopy'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-20', 'studyFirstSubmitDate': '2015-09-30', 'studyFirstSubmitQcDate': '2015-10-05', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adenomas and / or adenocarcinoma detected during each procedure (NBI vs Indigo carmine)', 'timeFrame': 'procedure time', 'description': 'The adenoma detection rate (number of adenoma and/or adenocarcinoma) of NBI and the additional adenoma detection rate of indigo carmine.'}], 'secondaryOutcomes': [{'measure': 'All neoplastic lesions detected during colonoscopy', 'timeFrame': 'procedure time', 'description': 'Collect the number, size, location, endoscopic (Paris Classification) and anatomo-pathologic aspect (adenoma, hyperplastic polyp, adenocarcinoma) of all detected lesions with their respective prevalence.'}, {'measure': 'Cost of each procedure (NBI vs Indigo carmine)', 'timeFrame': 'Procedure time', 'description': 'Evaluate the cost of each procedure including therapy.'}, {'measure': 'Duration of each procedure (NBI vs Indigo carmine)', 'timeFrame': 'Procedure time', 'description': 'Evaluate the duration of each procedure (with and without endoscopic therapy).'}, {'measure': 'Number of subject with adverse events as mesure of safety.', 'timeFrame': 'One month after colonoscopy', 'description': 'Followed a month post colonoscopy to evaluate the occurrence of undesirable events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Indigo carmine chromoendoscopy', 'Narrow band imaging', 'Colonoscopy'], 'conditions': ['Lynch Syndrome']}, 'referencesModule': {'references': [{'pmid': '31498154', 'type': 'DERIVED', 'citation': 'Cellier C, Perrod G, Colas C, Dhooge M, Saurin JC, Lecomte T, Coron E, Rahmi G, Savale C, Chaussade S, Bellanger J, Dray X, Benech N, Le Rhun M, Barbieux JP, Pereira H, Chatellier G, Samaha E. Back-to-Back Comparison of Colonoscopy With Virtual Chromoendoscopy Using a Third-Generation Narrow-Band Imaging System to Chromoendoscopy With Indigo Carmine in Patients With Lynch Syndrome. Am J Gastroenterol. 2019 Oct;114(10):1665-1670. doi: 10.14309/ajg.0000000000000386.'}]}, 'descriptionModule': {'briefSummary': 'This study compares two colonoscopy techniques (with Narrow Band Imaging versus with indigo carmine chromoendoscopy) in patients having Lynch Syndrome', 'detailedDescription': 'Chromoendoscopy using indigo carmine dye is recommended every 1 to 2 years in patients having Lynch Syndrome (LS). However, it is a time-consuming procedure, requiring a prior learning and has an additional cost, the reason why it is not yet systematically practiced in all endoscopy centers. The "Narrow Band Imaging" (NBI) is a recent virtual chromoendoscopy technique using optical filters at the light source of the endoscope to highlight the vascular structures of the mucosa by pressing a button. NBI is currently used to better characterize dysplasia lesions in the esophageal, gastric, and colon mucosa. A new generation (3rd generation) of NBI is currently available on some endoscopes, it can deliver more brightness and contrast, and could allow for better detection of flat lesions. Until today, no study has directly compared colonic chromoendoscopy with Indigo carmine to virtual chromoendoscopy with NBI (3rd generation) in LS patients. The hypothesis that this research aims to verify is that the new generation NBI system might do at least as well as indigo carmine in colonic adenoma detection in LS. This study aims to compare colonoscopy with virtual chromoendoscopy using 3rd generation NBI system to chromoendoscopy with indigo carmine in LS patients, in a back-to-back, prospective non inferiority design, in which all patients will have both techniques in the following order: NBI first followed by Indigo carmine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lynch Syndrome with an identified mutation in one of the genes MutL Homolog 1 (MLH1), MutL Homolog 2 (MLH2), MutS homolog6 (MSH6), PMS2 or epithelial cellular adhesion molecule (EpCAM)\n* Age between 18 and 80\n* Indication of a screening colonoscopy\n\nExclusion Criteria:\n\n* Any sign of intestinal occlusion contra-indicating bowel preparation\n* History of total or subtotal colectomy\n* Any serious medical condition contra-indicating colonoscopy under general anesthesia\n* Pregnant or breast feeding women\n* Any coagulation disorder contra-indicating biopsies or endoscopic resections\n* Any history of hypersensitivity to indigo carmine\n* Adults subject to a legal protection measure (guardianship or curatorship)'}, 'identificationModule': {'nctId': 'NCT02570516', 'acronym': 'LYNCH-CHROMO', 'briefTitle': 'NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Comparison of Colonoscopy With Virtual Chromoendoscopy Using 3rd Generation NBI System to Chromoendoscopy With Indigo Carmine in Lynch Patients.', 'orgStudyIdInfo': {'id': 'P140108'}, 'secondaryIdInfos': [{'id': '2015-A00552-47', 'type': 'OTHER_GRANT', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Indigo carmine colonoscopy', 'description': 'Colonoscopy using indigo carmine is performed in second place', 'interventionNames': ['Procedure: Colonoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'NBI colonoscopy', 'description': 'Colonoscopy using NBI is performed in first place', 'interventionNames': ['Procedure: Colonoscopy']}], 'interventions': [{'name': 'Colonoscopy', 'type': 'PROCEDURE', 'description': 'A double colonoscopy is performed in a back-to-back design using NBI chromoendoscopy then indigo carmine in each patient.', 'armGroupLabels': ['Indigo carmine colonoscopy', 'NBI colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69003', 'city': 'Lyon', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'HCL - Hôpital Edouard-Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '37170', 'city': 'Chambray-lès-Tours', 'state': 'Centre-Val de Loire', 'country': 'France', 'facility': 'CHRU de Tours - Hôpital Trousseau', 'geoPoint': {'lat': 47.33537, 'lon': 0.70286}}, {'zip': '44093', 'city': 'Nantes', 'state': 'Pays de la Loire Region', 'country': 'France', 'facility': 'CHU Nantes - Hôtel-Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP - Hôpital Européen Georges-Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'AP-HP - Hôpital Saint-Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'AP-HP - Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '94805', 'city': 'Villejuif', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Institut Gustave-Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'CHRISTOPHE CELLIER, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital europeen Georges Pompidou'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'ARC Foundation for Cancer Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}