Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-04-10 @ 12:45 AM
Study NCT ID:
NCT06903520
Status:
COMPLETED
Last Update Posted:
2025-03-30
First Post:
2025-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Correlation Study Between Anomalous Pancreaticobiliary Ductal Junction and Malignant Tumors of the Biliary System and the Establishment of an AI-based Automated Recognition System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080222', 'term': 'Pancreaticobiliary Maljunction'}], 'ancestors': [{'id': 'D003137', 'term': 'Common Bile Duct Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2439}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2025-03-28', 'studyFirstSubmitQcDate': '2025-03-28', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence rate of malignant tumors of the biliary system', 'timeFrame': '1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreaticobiliary Maljunction']}, 'descriptionModule': {'briefSummary': 'To explore the occurrence of pancreaticobiliary maljunction (PBM) in the Chinese population, the characteristics of various subtypes, and the relationship between PBM and malignant tumors of the biliary system. To explore the general clinical characteristics of patients with mild bile duct dilation but who have not been clinically diagnosed with choledochal cysts, as well as the relationship between these characteristics and malignant tumors of the biliary system. To develop and evaluate a deep learning method for machine learning of Magnetic resonance cholangiopancreatography (MRCP) images, enabling fully automated detection of pancreaticobiliary maljunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with pancreaticobiliary maljunction', 'eligibilityCriteria': "Inclusion Criteria:\n\nCases that were hospitalized and underwent Magnetic resonance cholangiopancreatography (MRCP) examination at the First Medical Center of Chinese People's Liberation Army General Hospital.\n\nExclusion Criteria:\n\n1. Patients aged less than 18 years old;\n2. Those with unclear diagnosis;\n3. Cases with missing or poor-quality imaging data."}, 'identificationModule': {'nctId': 'NCT06903520', 'briefTitle': 'Clinical Correlation Study Between Anomalous Pancreaticobiliary Ductal Junction and Malignant Tumors of the Biliary System and the Establishment of an AI-based Automated Recognition System', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Clinical Correlation Study Between Anomalous Pancreaticobiliary Ductal Junction and Malignant Tumors of the Biliary System and the Establishment of an AI-based Automated Recognition System', 'orgStudyIdInfo': {'id': '2023-037-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'country': 'China', 'facility': "Chinese People's Liberation Army General Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director', 'investigatorFullName': 'Lu Wenping', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}