Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-31 @ 3:00 PM
Study NCT ID:
NCT01198704
Status:
COMPLETED
Last Update Posted:
2020-11-20
First Post:
2010-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma (HCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood and serum sample (28 ml at M0, M3, M6) Tissues (one pretransplant, hepatic explant, potential resection)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 372}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-19', 'studyFirstSubmitDate': '2010-04-29', 'studyFirstSubmitQcDate': '2010-09-09', 'lastUpdatePostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive factors of HCC recurrence', 'timeFrame': 'at 2 years after Liver transplantation for HCC (modified by amendment on 17/10/2013)'}], 'secondaryOutcomes': [{'measure': 'Predictive factors of tumor-free recurrence', 'timeFrame': 'at 3 years'}, {'measure': 'Predictive factors of overall survival at 5 years', 'timeFrame': 'at 5 years'}, {'measure': 'Predictive factors of drop-out', 'timeFrame': 'during the waiting time'}, {'measure': 'Radio-pathological correlation', 'timeFrame': 'end of the study'}, {'measure': 'Correlation of HCC differentiation between liver biopsy and explant liver', 'timeFrame': 'at 32 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatocellular carcinoma', 'Cirrhosis', 'Transplantation'], 'conditions': ['Hepatocellular Carcinoma', 'Liver Cirrhosis', 'Evidence of Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'Results of liver transplantation, the best theoretical treatment for HCC, are limited by tumor recurrence. In order to limit this risk Milan criteria was proposed in 1996. However, these criteria are to restrictive and approximately 40% of patients denied by Milan criteria may be cured by liver transplantation.\n\nThe purpose of this study was thus to prospectively evaluate factors predicting tumor recurrence after liver transplantation for HCC and then to reassess criteria for liver transplantation.', 'detailedDescription': 'In this study, the investigators studied the predictive value of imaging techniques such as CT, MRI, PET scan, of serological markers and molecular markers assessed before liver transplantation at listing.\n\nThe investigators also evaluated the predictive value of tumor growing during the waiting time (imaging and serological).\n\nFinally, the investigators compared pre-LT data and explanted liver analysis to evaluate accuracy of liver biopsy and of imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient notified on the waiting list for hepatic transplant', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver cirrhosis\n* Hepatocellular carcinoma diagnosed by AASLD criteria or liver biopsy\n* Listing for Liver transplantation for HCC fulfilling or not Milan criteria\n* No extra-hepatic spread\n* No vascular involvement\n\nExclusion Criteria:\n\n* Salvage transplantation\n* Transplantation contra-indication\n* Evaluation for Liver transplantation older than 1 month\n* Incidental HCC'}, 'identificationModule': {'nctId': 'NCT01198704', 'acronym': 'EFAPRE', 'briefTitle': 'Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma (HCC)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'AOM07237'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HCC patients', 'description': 'Patients notified on the national waiting list for hepatic transplant', 'interventionNames': ['Other: search of factors predicting tumor recurrence']}], 'interventions': [{'name': 'search of factors predicting tumor recurrence', 'type': 'OTHER', 'description': 'Morphological, chronological, anatomy-pathological and molecular search', 'armGroupLabels': ['HCC patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': "Clinique Universitaire d'Hépato-gastroentérologie", 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Thomas Decaens, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}