Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT04768218
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2021-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BLI for the Diagnosis of Precancerous Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}], 'ancestors': [{'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': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-27', 'studyFirstSubmitDate': '2021-02-17', 'studyFirstSubmitQcDate': '2021-02-22', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the inter-observer agreement and accuracy of BLI system for the diagnosis and endoscopic staging of GIM', 'timeFrame': 'During the 3 months after finishing histopathological analysis of biopsies (an average of 17 months)', 'description': 'For accuracy: A per-biopsy analysis will be performed comparing diagnostic perception per site biopsied (ie, accuracy of WLE or BLI for each site observed vs that result).\n\nFor inter-observer agreement: after following educational set, inter-observer agreement for WLE and BLI will be assessed (see phase 2).'}, {'measure': 'To externally validate the EGGIM score classification using BLI', 'timeFrame': 'During the 12 months after finishing histopathological analysis of biopsies (an average of 17 months)', 'description': 'For accuracy: A per-patient analysis will be performed comparing WLE and BLI accuracy for Operative Link on Gastritis Assessment for Intestinal Metaplasia (OLGIM) III/IV (ie, accuracy of EGGIM estimated by each endoscopist using WLE or BLI towards OLGIM III/IV).\n\nFor inter-observer agreement: after completion phase 3, video records will be assessed by 1 endoscopist and inter-observer agreement for EGGIM classification, using BLI system, will be evaluated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer', 'Preneoplastic Condition', 'Early Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'Introduction: Traditionally, White Light Endoscopy (WLE), enhanced by biopsies following the updated Sydney system guidelines, has been the benchmark for diagnosing and classifying gastric preneoplastic conditions. Nevertheless, the pronounced interobserver variability and the often weak correlation between endoscopic observations and histopathological results have driven the increasing adoption of virtual chromoendoscopy (VCE). VCE technologies have demonstrated greater effectiveness in identifying these conditions compared to WLE, with Narrow Band Imaging (NBI) being particularly notable. Significantly, NBI has played a key role in validating the Endoscopic Grading of Gastric Intestinal Metaplasia (EGGIM) system. However, data on the effectiveness of other VCE technologies in this domain is relatively sparse in Europe, specifically with Blue Light Imaging (BLI), despite the promising diagnostic performance demonstrated with this technology.\n\nPrimary aim: to assess the diagnostic accuracy of BLI and to externally validate the applicability of EGGIM classification for staging GIM.\n\nMaterial and methods: a multicentric cohort study will be performed involving centres from two European countries (Portugal, Italy). Consecutive patients performing upper gastrointestinal endoscopy will be evaluated by WLE and BLI. Random biopsies or targeted plus random biopsies will be performed in order to determine de accuracy of BLI system to detect and stage GIM.\n\nExpected results: We anticipate that BLI would enable us to assess the extension of GIM without the need for biopsies. If observed, this would overall improve the upper GI endoscopy accuracy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred to the endoscopy department of a tertiary care center for screening or surveillance upper gastrointestinal endoscopy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals older than 18 years.\n* Indication to submit diagnostic or surveillance upper GI endoscopy.\n\nExclusion Criteria:\n\n* History of previous gastric surgery.\n* History of previous gastric cancer.\n* Contraindications to biopsies.\n* Individuals unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT04768218', 'briefTitle': 'BLI for the Diagnosis of Precancerous Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Portugues de Oncologia, Francisco Gentil, Porto'}, 'officialTitle': 'Blue Light Imaging System for the Diagnosis of Precancerous Conditions: European Multicenter Validation Study', 'orgStudyIdInfo': {'id': '207/020'}}, 'contactsLocationsModule': {'locations': [{'city': 'Porto', 'country': 'Portugal', 'facility': 'Marta Rodriguez', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Portugues de Oncologia, Francisco Gentil, Porto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}