Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-01-10 @ 4:07 AM
Study NCT ID:
NCT03708705
Status:
UNKNOWN
Last Update Posted:
2018-10-19
First Post:
2018-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liquid Biopsy-based Monitoring System for Relapse of HCC After Liver Transplantation: A Multi-center and Prospective Study
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and tissue samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-11-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-18', 'studyFirstSubmitDate': '2018-10-13', 'studyFirstSubmitQcDate': '2018-10-16', 'lastUpdatePostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'relapse rate of tumor', 'timeFrame': 'two years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study aims to develop a novel, reliable, liquid biopsy-based biomarker system for relapse of HCC associated with hepatitis B after liver transplantation.', 'detailedDescription': 'Relapse of hepatocellular carcinoma (HCC) is one of the leading causes of death after liver transplantation (LT). Detection of cancer at an earlier stage of the disease can be critical to improve patient survival. Liquid biopsy is a revolutionary technique that is opening previously unexpected perspectives. It consists of circulating extracellular vesicles, nucleic acids (DNA and RNA) and circulating tumor cells. The detection and isolation of circulating tumor cells, circulating tumor DNA and exosomes, as a source of genomic and proteomic information in patients with cancer. Regarding these promising and potential transformative tools, as well as the issues still needed to be addressed for adopting various liquid biopsy approaches into clinical practice. This study aims to develop a novel, reliable, liquid biopsy-based biomarker system for relapse of HCC associated with hepatitis B after liver transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'hospitalization patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ntransplants for HCC\n\nExclusion Criteria:\n\nLiver transplantation due to other disease'}, 'identificationModule': {'nctId': 'NCT03708705', 'briefTitle': 'Liquid Biopsy-based Monitoring System for Relapse of HCC After Liver Transplantation: A Multi-center and Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Liquid Biopsy-based Monitoring System for Relapse of Hepatocellular Carcinoma Associated With Hepatitis B After Liver Transplantation: A Multi-center and Prospective Study', 'orgStudyIdInfo': {'id': 'ZJUXU1177'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Relapse', 'description': 'Relapse of tumor within two years after liver transplantation', 'interventionNames': ['Other: Risk model of tumor relapse']}, {'label': 'Non-relapse', 'description': 'Non-relapse of tumor within two years after liver transplantation', 'interventionNames': ['Other: Risk model of tumor relapse']}], 'interventions': [{'name': 'Risk model of tumor relapse', 'type': 'OTHER', 'otherNames': ['Risk model'], 'description': 'High risk factor model of tumor relapse after liver transplantation', 'armGroupLabels': ['Non-relapse', 'Relapse']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Two years', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Xiao Xu', 'investigatorAffiliation': 'Zhejiang University'}}}}