Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-02-28 @ 9:25 PM
Study NCT ID:
NCT06787534
Status:
COMPLETED
Last Update Posted:
2025-01-22
First Post:
2025-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Favorable Impact of HBcAb Positive Grafts on Liver Transplantation for HBV-related HCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6924}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-20', 'studyFirstSubmitDate': '2025-01-14', 'studyFirstSubmitQcDate': '2025-01-20', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative death', 'timeFrame': '2015.1.1-2023.12.31', 'description': 'The death of a patient following liver transplanation'}], 'secondaryOutcomes': [{'measure': 'Postoperative recurrence', 'timeFrame': '2015.1.1-2023.12.31', 'description': 'The day of hepatocellular carcinoma recurrence'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'The utilization of marginal grafts may help alleviate the demand mismatch. However, strategies to optimize the use of hepatitis B core antibody (HBcAb) positive grafts still requires further investigation. This study aims to investigate possible interactions between HBcAb positive grafts, HCC and HBV-related diseases, and long-term patient and graft survival. The study retrospectively analyzed patients undergoing liver transplantation in 8 centers between January 2015 and December 2020.', 'detailedDescription': 'This retrospective observational study included patients who underwent liver transplantation between January 2015 and December 2020 from 8 transplant centers in China, including the First Affiliated Hospital, Zhejiang University School of Medicine, Shulan (Hangzhou) Hospital, the Affiliated Hospital of Qingdao University, the Third Affiliated Hospital of Sun Yat-sen University, West China Hospital of Sichuan University, HuaShan Hospital of Fudan University, Beijing Chaoyang Hospital of Capital Medical University, and the Second Xiangya Hospital of Central South University. Demographic and clinicopathological data of these patients were extracted from the prospectively maintained China Liver Transplant Registry (CLTR) database. The exclusion criteria were as follows: (1) re-transplantation, combined organ transplantation or living donor liver transplantation; (2) intrahepatic cholangiocarcinoma or combined hepatocellular-cholangiocarcinoma; (3) HBsAg positive graft; and (4) missing of baseline data. Patients who were lost to follow-up were also excluded.\n\nStatistical analysis was performed with GraphPad Prism (Version 9), IBM SPSS Statistics (Version 26) and R version 4.3.1 (R Foundation). Regarding the initial demographic data, continuous variables were depicted as medians (IQR: Inter-Quartile Range) and analyzed for differences with the Mann-Whitney U test. Categorical variables were contrasted through the application of the chi-squared test. Cumulative patient survival, graft survival, recurrence-free survival and recurrence rate were analyzed by the Kaplan-Meier method and compared with the log-rank test. To lessen the impact of potential confounders and selection bias, propensity score matching (PSM) was implemented to form comparable groups. Unbalanced variables were entered into the 1:1 matching model. Cox proportional hazard models were used to estimate hazard ratios (HRs) with 95% confidence intervals (CIs) for the relationship between variables and the event of interest. Univariate analyses were performed to identify the potential risk factors for patient survival, graft survival and recurrence-free survival in each group. Variables (P\\<0.10) were included in the backward stepwise multivariate analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Of the patients, 18.4% were female, and the median age of the patients was 50 years (range 18-82 years; IQR 43-56 years). The median value of the laboratory MELD score was 25 (IQR 13-35). The median follow-up duration for the study cohort was 44.7 months (IQR 16.0-65.3 months).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) primary transplantation; (2) complete baseline data.\n\nExclusion Criteria:\n\n* (1) re-transplantation, combined organ transplantation or living donor liver transplantation; (2) intrahepatic cholangiocarcinoma or combined hepatocellular-cholangiocarcinoma; (3) HBsAg positive graft; and (4) missing of baseline data. Patients who were lost to follow-up were also excluded.'}, 'identificationModule': {'nctId': 'NCT06787534', 'briefTitle': 'The Favorable Impact of HBcAb Positive Grafts on Liver Transplantation for HBV-related HCC', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'The Favorable Impact of Hepatitis B Core Antibody Positive Grafts on Liver Transplantation for Hepatitis B Virus-related Hepatocellular Carcinoma: a Nationwide Multicenter Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'CT-2025-ZJU-OBS01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HBcAb negative group', 'description': 'Liver transplant recipients with HBcAb negative grafts', 'interventionNames': ['Other: No Interventions']}, {'label': 'HBcAb positive group', 'description': 'Liver transplant recipients with HBcAb positive grafts', 'interventionNames': ['Other: No Interventions']}], 'interventions': [{'name': 'No Interventions', 'type': 'OTHER', 'armGroupLabels': ['HBcAb negative group', 'HBcAb positive group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiao Xu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Xiao Xu', 'investigatorAffiliation': 'Zhejiang University'}}}}