Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 6:13 PM
Study NCT ID:
NCT05171634
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2021-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Artificial Intelligence and Dysplasia Detection in Ulcerative Colitis (CUDISIA Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-08', 'studyFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2021-12-17', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '"Per lesion" dysplasia detection rate (DDR)', 'timeFrame': 'Immediately after the procedure.', 'description': 'Proportion of dysplastic lesions in relation to all the lesions analyzed that were detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN in patients with long-standing Ulcerative Colitis who undergo surveillance colonoscopy.'}, {'measure': '"Per patient" dysplasia detection rate (DDR)', 'timeFrame': 'Immediately after the procedure.', 'description': 'Proportion of patients with dysplastic lesions in relation to all the patients with long-standing Ulcerative Colitis included in the study detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual chromoendoscopy', 'Artificial intelligence', 'iSCAN', 'Dysplasia'], 'conditions': ['Ulcerative Colitis', 'Dysplasia']}, 'referencesModule': {'references': [{'pmid': '38740327', 'type': 'RESULT', 'citation': 'Lopez-Serrano A, Voces A, Lorente JR, Santonja FJ, Algarra A, Latorre P, Del Pozo P, Paredes JM. Artificial intelligence for dysplasia detection during surveillance colonoscopy in patients with ulcerative colitis: A cross-sectional, non-inferiority, diagnostic test comparison study. Gastroenterol Hepatol. 2025 Feb;48(2):502210. doi: 10.1016/j.gastrohep.2024.502210. Epub 2024 May 11. English, Spanish.'}], 'seeAlsoLinks': [{'url': 'https://www.elsevier.es/es-revista-gastroenterologia-hepatologia-14-linkresolver-artificial-intelligence-for-dysplasia-detection-S0210570524001687', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Prospective clinical study that analyzes the efficacy of colonoscopy assisted by an artificial intelligence system (DiscoveryTM) compared to virtual chromoendoscopy with iSCAN in the detection of colon dysplasia in patients with long-standing Ulcerative Colitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ulcerative Colitis confirmed by endoscopy and histology.\n* Involvement 30% of the colonic surface (or any extent if concomitant with PSC).\n* Duration of the disease \\>7 years (or any duration if concomitant with PSC).\n\nExclusion Criteria:\n\n* Personal history of colorectal cancer or high-grade dysplasia.\n* Previous colectomy (partial or complete).\n* Coagulopathy that prevents biopsies or polypectomy.\n* Colonoscopy performed in the previous 6 months.\n* Pregnant or nursing women.\n* Inadequate bowel preparation.\n* Presence of endoscopic Ulcerative Colitis activity.\n* Colonic stenosis and incomplete colonoscopy.'}, 'identificationModule': {'nctId': 'NCT05171634', 'acronym': 'CUDISIA', 'briefTitle': 'Artificial Intelligence and Dysplasia Detection in Ulcerative Colitis (CUDISIA Study)', 'organization': {'class': 'OTHER', 'fullName': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana'}, 'officialTitle': 'Impact of Artificial Intelligence in Dysplasia Detection During Colonoscopy in Patients With Long-data Ulcerative Colitis: a Crossover Study', 'orgStudyIdInfo': {'id': 'CEIm: 62.21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Colonoscopy assisted by DiscoveryTM', 'interventionNames': ['Device: DiscoveryTM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Virtual Colonoscopy with iSCAN', 'interventionNames': ['Device: iSCAN']}], 'interventions': [{'name': 'DiscoveryTM', 'type': 'DEVICE', 'description': 'Colonoscopy assisted by an artificial intelligence system (DiscoveryTM).', 'armGroupLabels': ['Colonoscopy assisted by DiscoveryTM']}, {'name': 'iSCAN', 'type': 'DEVICE', 'description': 'Virtual colonoscopy assisted by iSCAN', 'armGroupLabels': ['Virtual Colonoscopy with iSCAN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46017', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Antonio López-Serrano', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Valencia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Endoscopy', 'investigatorFullName': 'Antonio López-Serrano', 'investigatorAffiliation': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana'}}}}