Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-04-15 @ 9:20 PM
Study NCT ID:
NCT04412161
Status:
COMPLETED
Last Update Posted:
2020-06-02
First Post:
2020-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liver Transplant for Larger Hepatocellular Carcinoma in Malatya: The Role of GGT and AFP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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'}]}, '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': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-29', 'studyFirstSubmitDate': '2020-05-29', 'studyFirstSubmitQcDate': '2020-05-29', 'lastUpdatePostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall and disease free survivals', 'timeFrame': 'five years follow up', 'description': 'to analyse the factors that effect the survivals'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatic malignancy', 'GGT', 'living donor'], 'conditions': ['Hepatocellular Carcinoma', 'Liver Transplant Disorder']}, 'descriptionModule': {'briefSummary': 'Retrospective data on 50 prospectively-collected HCC patients with beyond-Milan criteria with \\>6cm tumors were analyzed. 5-year OS of 76.2% was found in patients with both AFP \\<200 ng/ml and GGT \\<104 IU/mL with tumors less than 10 cm diameter. Thus, GGT values add to AFP in patient prognosis.', 'detailedDescription': 'Background:A retrospective analysis was performed of prospectively-collected transplant data on outcomes of patients with large size HCCs,to examine possible prognostically-useful factors.Methods:A total of 50 patients having tumors greater than 6cm maximum diameter were identified. Their survival and full clinical characteristics were examined, with respect to serum AFP and GGT levels.Results:Using ROC analysis, cutoff values of AFP 200 ng/ml and GGT 104 IU/ml were identified and used in this study. Significantly longer overall-survival and disease-free-survival were found for patients who had lower values of either parameter, compared with higher values.Even greater differences in survival were found when the 2 parameters were combined, with best survival (5-year OS of 76,2% versus 0%, p=0.002).The most consistent clinical correlates for these longer survivals were degree of tumor differentiation and absence of microscopic portal venous invasion.Two tumor size bands were identified,to search for the limits of this approach with larger tumors, namely 6-10 and \\>10cm.Combination parameters in 6-10cm band reflected 5-year OS of 76,2% vs. 0%,in patients with low AFP plus low GGT vs. other groups.Beyond 10cm,no patients had low AFP plus low GGT.Conclusions:AFP and GGT,both singly and together, represent a simple prognostic identifier for patients with large size HCCs being treated by liver transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Liver transplant patients with maximum tumor diameter greater than 6 cm of hepatocellular carcinoma', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver transplant patients with maximum tumor diameter greater than 6 cm of hepatocellular carcinoma\n\nExclusion Criteria:\n\n* Early postoperative mortality (within 90 days)\n* Advanced stage tumors (explant patology revealed that tumor continues in the surgical cite such as positive lymph node metastases, macroscopic portal vein trombosis, diaphragmatic invasion, etc)'}, 'identificationModule': {'nctId': 'NCT04412161', 'briefTitle': 'Liver Transplant for Larger Hepatocellular Carcinoma in Malatya: The Role of GGT and AFP', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'Retrospective Cohort Study-Analysis of LT Patients With HCC (Maximum Tumor Diameter > 6 cm).', 'orgStudyIdInfo': {'id': 'GGT-HCC-6CM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Extra-Malatya', 'description': 'Liver transplant patients with MTD\\>6 cm of HCC', 'interventionNames': ['Procedure: Liver transplantation']}], 'interventions': [{'name': 'Liver transplantation', 'type': 'PROCEDURE', 'description': 'Living donor liver transplantation', 'armGroupLabels': ['Extra-Malatya']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, FEBS, Assoc.Prof', 'investigatorFullName': 'Volkan Ince', 'investigatorAffiliation': 'Inonu University'}}}}