Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-17 @ 6:50 PM
Study NCT ID:
NCT02328066
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2014-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062048', 'term': 'Narrow Band Imaging'}], 'ancestors': [{'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-26', 'studyFirstSubmitDate': '2014-12-08', 'studyFirstSubmitQcDate': '2014-12-26', 'lastUpdatePostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of NICE classification to predict deep submucosal invasion', 'timeFrame': '1 year', 'description': 'Sensibility, specificity, negative predictive value and positive predictive value of NICE classification to predict deep submucosal invasion during routine colonoscopies.\n\nGold standard (histology):\n\n* positive means adenocarcinoma with deep submucosal invasion (\\>1 mm)\n* negative means non adenocarcinoma or superficial adenocarcinoma (\\<1 mm)\n\nEvaluated test (NICE classification):\n\n* Positive means NICE type 3.\n* Negative means NICE type 1 and 2.\n\nEvaluated test (NICE classification) was blinded to the pathologist who performed the gold standard test (histology)'}], 'secondaryOutcomes': [{'measure': 'Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the pre-learning test', 'timeFrame': '0', 'description': 'Sensibility, specificity, negative predictive value and positive predictive value of NICE classification to predict deep submucosal invasion in the pre-learning test.'}, {'measure': 'Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the post-learning test', 'timeFrame': '0', 'description': 'Sensibility, specificity, negative predictive value and positive predictive value of NICE classification to predict deep submucosal invasion in the post-learning test (pre-clinical test)'}, {'measure': 'Preplanned potential factors that could influence diagnostic accuracy of NICE classification', 'timeFrame': '1 year', 'description': "Related to the lesion: Size (mm); location: rectum/sigmoid/left colon/splenic flexure/transverse colon/hepatic flexure/right colon and cecum; Morphology according to the Paris classification (see categories in the reference article); Level of confidence: high/low; Successful complete submucosal injection: yes/no/not done; Chicken skin's sign: yes/no; Edges retraction: yes/no; Depressed areas: yes/no; Folds convergence: yes/no; Induration: yes/no; Obvious ulceration: yes/no; Polyp on polyp: yes/no; Technical resection: 8 categories according to the current practice.\n\nRelated to the equipment: Colonoscope: 11 colonoscope models; Videoprocessor: Exera II, Exera III; Monitor: high definition, non-high definition\n\nRelated to the endoscopist: Hospital type: Secondary or tertiary; Endoscopy experience (number of years); Previous experience in chromoendoscopy: yes/no; Previous experience in NBI: yes/no; Number of lesions included in the study; Review histology and images monthly: yes/no"}, {'measure': 'Histological predictors of lymph node metastases of pT1', 'timeFrame': '1 year', 'description': '* Histological type: adenocarcinoma, mucinous adenocarcinoma, cell carcinoma with signet ring, undifferentiated carcinoma, other.\n* Histologic Grade: Low Grade (well-moderately differentiated) or High-grade (poorly dif, undifferentiated, mucinous, signet ring).\n* Horizontal size of adenocarcinoma (mm)\n* Level of submucosal adenocarcinoma (mm)\n* Angiolymphatic invasion of small vessels: Present or absent\n* Perineural invasion: Present or Absent.\n* Tumor budding: Absent, Low grade (5-9 groups of 5 cells per field with 20x objective), High Grade (≥10 groups of 5 cells per field with 20x objective)\n* Polyp type that originated carcinoma: Tubular adenoma, Villous adenoma, Adenoma/sessile serrated polyp, Traditional serrated adenoma, Other\n* Resection margin: Negative or Positive\n* Size of negative margin (mm).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NBI', 'NICE classification', 'deep submucosal invasion', 'Colonic Polyps [C23.300.825.411.235]', 'Colonoscopy [E01.370.372.250.250.200]'], 'conditions': ['Colonic Polyps']}, 'referencesModule': {'references': [{'pmid': '23910062', 'type': 'BACKGROUND', 'citation': 'Hayashi N, Tanaka S, Hewett DG, Kaltenbach TR, Sano Y, Ponchon T, Saunders BP, Rex DK, Soetikno RM. Endoscopic prediction of deep submucosal invasive carcinoma: validation of the narrow-band imaging international colorectal endoscopic (NICE) classification. Gastrointest Endosc. 2013 Oct;78(4):625-32. doi: 10.1016/j.gie.2013.04.185. Epub 2013 Jul 30.'}, {'pmid': '30296432', 'type': 'DERIVED', 'citation': 'Puig I, Lopez-Ceron M, Arnau A, Rosinol O, Cuatrecasas M, Herreros-de-Tejada A, Ferrandez A, Serra-Burriel M, Nogales O, Vida F, de Castro L, Lopez-Vicente J, Vega P, Alvarez-Gonzalez MA, Gonzalez-Santiago J, Hernandez-Conde M, Diez-Redondo P, Rivero-Sanchez L, Gimeno-Garcia AZ, Burgos A, Garcia-Alonso FJ, Bustamante-Balen M, Martinez-Bauer E, Penas B, Pellise M; EndoCAR group, Spanish Gastroenterological Association and the Spanish Digestive Endoscopy Society. Accuracy of the Narrow-Band Imaging International Colorectal Endoscopic Classification System in Identification of Deep Invasion in Colorectal Polyps. Gastroenterology. 2019 Jan;156(1):75-87. doi: 10.1053/j.gastro.2018.10.004. Epub 2018 Oct 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the diagnostic accuracy of NICE classification to predict deep submucosal invasion of colonic polyps \\> 1 cm, considering histology as the gold standard, in a group of endoscopists who previously performed a training program.', 'detailedDescription': 'In the first phase of the study, a learning program of NICE classification based on examples will be performed. Forty images will be evaluated before and after the learning program.\n\nIn the second phase of the study, all consecutive patients who underwent to a colonoscopy will be included if a lesion greater than 1 cm is found and the endoscopy is performed with a high definition colonoscope with Narrow Band Imaging (NBI). Patients, lesions and endoscopy equipment characteristics will be recorded.\n\nSubsequently, histological diagnosis of the lesion will also be recorded. Evaluated test (NICE classification) was blinded to the pathologist who performed the gold standard test (histology). In case of adenocarcinomas, histological predictors of lymph node metastases, with predefined assessment criteria, will also be recorded.\n\nFinally, histological preparations of adenocarcinomas will be sent to the reference center and two experienced pathologists will examine them again.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion patients criteria:\n\n* Patients\\> 18 years\n* Lesion Type 0 of Paris classification, greater than 1 cm, found in a colonoscopy performed by any medical indication with a high definition endoscope with Narrow Band Imaging.\n* Achievable histology by endoscopic or surgical resection.\n* Writing informed consent given.\n\nExclusion patients criteria:\n\n* Age \\<18 years.\n* Refusal to give informed consent.\n* Contraindication for endoscopic or surgical resection.\n* Urgent colonoscopy indication (eg severe rectorrhagia.).\n* Patients with inflammatory bowel disease.\n* Suspected metastatic neoplasia by previous imaging tests.\n\nExclusion lesions criteria:\n\n* Polyp previously biopsied or resected.\n* Poor preparation that does not allow a proper assessment of the lesion.\n* NBI not performed.\n* Unavailable or indefinite histology (endoscopic or surgical resection).'}, 'identificationModule': {'nctId': 'NCT02328066', 'acronym': 'NICE', 'briefTitle': 'Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion', 'organization': {'class': 'OTHER', 'fullName': 'Asociación Española de Gastroenterología'}, 'officialTitle': 'Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion in Colon Lesions. Prospective Multicenter Study in Routine Clinical Practice', 'orgStudyIdInfo': {'id': 'CEIC14/47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NBI used by trained endoscopists', 'description': 'Assessment with NICE classification and NBI technology of colonic lesions (Paris classification type 0) greater than 1 cm found in a routine colonoscopy. This assessment was performed by previously trained endoscopists.', 'interventionNames': ['Device: NBI used by trained endoscopists']}], 'interventions': [{'name': 'NBI used by trained endoscopists', 'type': 'DEVICE', 'otherNames': ['Narrow Band Imaging', 'NICE classification'], 'description': 'Examination of colon lesions, using NBI and NICE classification, by endoscopists who previously performed an easy learning program. The learning program consists on the reading of two reference articles and a tutorial explaining the NICE classification. This tutorial shows several lesions and describes the characteristic features in which the classifications focus on.', 'armGroupLabels': ['NBI used by trained endoscopists']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08241', 'city': 'Manresa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Ignasi Puig', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}], 'overallOfficials': [{'name': 'Pablo Vega', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Complexo Hospitalario de Ourense'}, {'name': 'Maria Luisa de Castro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Complexo Hospitalario Universitario de Vigo-CHUVI'}, {'name': 'Eva Martínez-Bauer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corporacion Parc Tauli'}, {'name': 'Angel Fernández', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clínico de Zaragoza'}, {'name': 'Gema de la Poza', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Fuenlabrada'}, {'name': 'Jorge López', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Móstoles'}, {'name': 'Oscar Nogales', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gregorio Marañón Hospital'}, {'name': 'Beatriz Peñas', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Ramon y Cajal'}, {'name': 'Pilar Díez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Río Ortega'}, {'name': 'Marta Hernández', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Puerta de Hierro'}, {'name': 'Antonio Zebenzuy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario de Canarias'}, {'name': 'Aurora Burgos', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario La Paz'}, {'name': 'Jorge Mendoza', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundación de Investigación Biomédica - Hospital Universitario de La Princesa'}, {'name': 'Marco Antonio Álvarez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital del Mar'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asociación Española de Gastroenterología', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}