Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT06114251
Status:
COMPLETED
Last Update Posted:
2023-11-02
First Post:
2023-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hepatitis B Virus Reactivation: a Cautionary Event After Liver Transplantation for Patients With Hepatocellular Carcinoma
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': 920}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-27', 'studyFirstSubmitDate': '2023-10-27', 'studyFirstSubmitQcDate': '2023-10-27', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative recurrence of liver cancer', 'timeFrame': '2015.1.1-2020.12.31'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplant; Complications']}, 'referencesModule': {'references': [{'pmid': '38348848', 'type': 'DERIVED', 'citation': 'Li H, Lu D, Chen J, Zhang J, Zhuo J, Lin Z, Cao C, Shen W, He C, Chen H, Hu Z, Sun Y, Wei X, Zhuang L, Zheng S, Xu X. Post-transplant hepatitis B virus reactivation impacts the prognosis of patients with hepatitis B-related hepatocellular carcinoma: a dual-centre retrospective cohort study in China. Int J Surg. 2024 Apr 1;110(4):2263-2274. doi: 10.1097/JS9.0000000000001141.'}]}, 'descriptionModule': {'briefSummary': 'Highly active hepatitis B virus (HBV) is known to be associated with poor outcomes in patients with hepatocellular carcinoma (HCC). This study aims to investigate the relationship between HBV status and HCC recurrence after liver transplantation. The study retrospectively analyzed HCC patients undergoing liver transplantation in 2 centers between January 2015 and December 2020. We reviewed post-transplant HBV status and its association with outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'From January 2015 to December 2020, the electronic medical records of liver cancer patients who underwent liver transplantation at the First Affiliated Hospital, Zhejiang University School of Medicine and Shulan (Hangzhou) Hospital were retrospectively reviewed.Recipients were followed up after liver transplantation until Dec 31, 2022. During the follow-up period, the recipients were managed according to a standard protocol. All recipients received a nucleoside analog after liver transplantation. HBV serological markers, such as hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg) and HBV DNA were monitored regularly. The alpha-fetoprotein (AFP) level was determined every 1-2 months. The ultrasound or computed tomography or magnetic resonance imaging was performed every 3-6 months in HCC patients who underwent liver transplantation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) preoperative diagnosis of HBV-related HCC and (2) pathologically confirmed HCC.\n\nExclusion criteria\n\n* (1) non-HBV-related HCC; (2) simultaneous presence of other tumors; (3) re-transplantation; (4) presence of portal vein tumor thrombus; and (5) a survival time of less than 90 days.'}, 'identificationModule': {'nctId': 'NCT06114251', 'briefTitle': 'Hepatitis B Virus Reactivation: a Cautionary Event After Liver Transplantation for Patients With Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Hepatitis B Virus Reactivation: a Cautionary Event After Liver Transplantation for Patients With Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'CT2023-ZJU-OBS2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'First Affiliated Hospital, Zhejiang University School of Medicine', 'interventionNames': ['Diagnostic Test: Diagnosis of postoperative recurrence of liver cancer']}, {'label': 'Shulan (Hangzhou) Hospital', 'interventionNames': ['Diagnostic Test: Diagnosis of postoperative recurrence of liver cancer']}], 'interventions': [{'name': 'Diagnosis of postoperative recurrence of liver cancer', 'type': 'DIAGNOSTIC_TEST', 'description': 'HBV serological markers, such as hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg) and HBV DNA were monitored regularly. The alpha-fetoprotein (AFP) level was determined every 1-2 months. The ultrasound or computed tomography or magnetic resonance imaging was performed every 3-6 months in HCC patients who underwent liver transplantation.', 'armGroupLabels': ['First Affiliated Hospital, Zhejiang University School of Medicine', 'Shulan (Hangzhou) Hospital']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiao Xu', 'investigatorAffiliation': 'Zhejiang University'}}}}