Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2026-03-16 @ 12:07 AM
Study NCT ID:
NCT05200195
Status:
COMPLETED
Last Update Posted:
2022-06-30
First Post:
2022-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep Learning Model for the Prediction of Post-LT HCC Recurrence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016031', 'term': 'Liver Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4026}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-27', 'studyFirstSubmitDate': '2022-01-07', 'studyFirstSubmitQcDate': '2022-01-19', 'lastUpdatePostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-transplant HCC recurrence', 'timeFrame': '5 years from liver transplantation', 'description': 'Intra- and/or extrahepatic recidivism of HCC after liver transplantation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['artificial intelligence', 'deep learning', 'mathematical model'], 'conditions': ['Liver Transplant Disorder', 'Liver Cancer', 'Recurrent Cancer']}, 'descriptionModule': {'briefSummary': 'Identifying patients at high risk for recurrence of hepatocellular carcinoma (HCC) after liver transplantation (LT) represents a challenging issue. The present study aims to develop and validate an accurate post-LT recurrence prediction calculator using the machine learning method.', 'detailedDescription': 'In 1996, the introduction of the Milan criteria (MC) strongly modified the selection process of hepatocellular cancer (HCC) patients waiting for liver transplantation (LT). Many attempts to widen MC have been proposed. Initially, exclusively morphology-based (nodules number and target lesion diameter) criteria were created. In the last years, extended criteria also based on biological parameters have been added. Among the most adopted biology-based features, the levels of different tumor markers, liver function parameters like the model for end-stage liver disease (MELD), the radiological response after neo-adjuvant therapies, and the length of waiting-time (WT) can be reported.\n\nUnfortunately, all the proposed models showed suboptimal prediction abilities for the risk of post-LT recurrence. Such impairment was derived from the limitations of the standard statistical methods to account for many variables and their non-linear interactions. Therefore, developing a model based on Artificial Intelligence (AI) represents an attractive way to improve prediction ability.\n\nThus, the investigators hypothesize that an AI model focused on an accurate post-transplant HCC recurrence prediction should improve our ability to pre-operatively identify patients with different classes of risk for HCC recurrence after transplant.\n\nThis study aims to develop an AI-derived prediction model combining morphology and biology variables. A Training Set derived from an International Cohort was adopted for doing this. A Test Set derived from the same International Cohort and a Validation Cohort were adopted for the internal and external validation, respectively. A user-friendly web calculator was also developed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All the consecutive adult (≥18 years) patients enlisted and transplanted with the primary diagnosis of HCC during the period 2000-2018 in the 18 centers composing the International and the Validation Cohorts', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive adult (≥18 years) patients enlisted and transplanted with the primary diagnosis of HCC during the period 2000-2018.\n\nExclusion Criteria:\n\n* Patients with HCC diagnosed only at pathological examination (incidental HCC)\n* Patients with mixed hepatocellular-cholangiocellular cancer misdiagnosed as HCC\n* Patients with cholangiocellular cancer misdiagnosed as HCC\n* Patients dying early after LT (≤ one month)'}, 'identificationModule': {'nctId': 'NCT05200195', 'acronym': 'TRAIN-AI', 'briefTitle': 'Deep Learning Model for the Prediction of Post-LT HCC Recurrence', 'organization': {'class': 'OTHER', 'fullName': 'European Hepatocellular Cancer Liver Transplant Group'}, 'officialTitle': 'Development and Validation of a Deep Learning Model for the Prediction of Hepatocellular Cancer Recurrence After Transplantation: The Time-Radiological Response- AlphafetoproteIN-Artificial Intelligence Model', 'orgStudyIdInfo': {'id': '#004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'International Cohort Training Set', 'description': 'The Training Set of the International Cohort (N=3,670) was composed of the 80% (n=2936) HCC patients transplanted from 2000 to 2018 across 17 centers in Europe and Asia.', 'interventionNames': ['Procedure: Liver transplantation']}, {'label': 'International Cohort Test Set', 'description': 'The Test Set of the International Cohort (N=3,670) was composed of the 20% (n=734) HCC patients transplanted from 2000 to 2018 across 17 centers in Europe and Asia.', 'interventionNames': ['Procedure: Liver transplantation']}, {'label': 'Validation Cohort', 'description': 'The external Validation Cohort was composed of 356 HCC patients transplanted at the Columbia University, New York, during the period 2000-2018.', 'interventionNames': ['Procedure: Liver transplantation']}], 'interventions': [{'name': 'Liver transplantation', 'type': 'PROCEDURE', 'description': 'Deceased or living donor liver transplantation for the cure of hepatocellular cancer on cirrhosis', 'armGroupLabels': ['International Cohort Test Set', 'International Cohort Training Set', 'Validation Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00151', 'city': 'Rome', 'state': 'RM', 'country': 'Italy', 'facility': 'Quirino Lai', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Quirino Lai, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Roma La Sapienza'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Hepatocellular Cancer Liver Transplant Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Quirino Lai', 'investigatorAffiliation': 'European Hepatocellular Cancer Liver Transplant Group'}}}}