Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT05352204
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2022-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Tumor Micronecrosis on Postoperative Transcatheter Arterial Chemoembolization in Patients With Hepatocellular Carcinomas
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-11', 'studyFirstSubmitDate': '2022-04-22', 'studyFirstSubmitQcDate': '2022-04-22', 'lastUpdatePostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'after liver resection until June 1, 2020', 'description': 'the number of months from the date of surgery to the date of the last follow-up visit or time of death.'}], 'secondaryOutcomes': [{'measure': 'disease-free survival', 'timeFrame': 'after liver resection until June 1, 2020', 'description': 'the number of months from the date of surgery to the date of first confirmable recurrence or death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hepatocellular carcinoma', 'TACE', 'tumor necrosis'], 'conditions': ['Carcinoma, Hepatocellular']}, 'descriptionModule': {'briefSummary': 'Micronecrosis is a novel pathological feature of hepatocellular carcinoma (HCC). This study was aimed at evaluating the effect of tumor micronecrosis on postoperative transcatheter arterial chemoembolization (TACE) in patients with hepatocellular carcinomas, and further exploring the value of micronecrosis for guiding TACE in HCC management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'From June 2014 to April 2018, HCC patients who underwent liver resection in our center were retrospectively reviewed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) pathologically confirmed HCC (2) achievement of R0 resection.\n\nExclusion Criteria:\n\n* (1) simultaneous presence of other tumors ; (2) receipt of preoperative anti-tumoral treatments; (3) concurrent treatment with other antitumoral therapies in combination with TACE; (4) tumor necrosis that could be observed by gross examination; (5) a lack of necessary preoperative laboratory test results.'}, 'identificationModule': {'nctId': 'NCT05352204', 'briefTitle': 'Effect of Tumor Micronecrosis on Postoperative Transcatheter Arterial Chemoembolization in Patients With Hepatocellular Carcinomas', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'The Guiding Value of Tumor Micronecrosis for Using Postoperative Transcatheter Arterial Chemoembolization in Patients With Hepatocellular Carcinomas', 'orgStudyIdInfo': {'id': 'PTHCC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'micronecrosis(+) group', 'interventionNames': ['Procedure: transcatheter arterial chemoembolization']}, {'label': 'micronecrosis(-) group'}], 'interventions': [{'name': 'transcatheter arterial chemoembolization', 'type': 'PROCEDURE', 'description': 'transcatheter arterial chemoembolization after liver resection', 'armGroupLabels': ['micronecrosis(+) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'the First Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'the First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'FACS', 'investigatorFullName': 'TingBo Liang', 'investigatorAffiliation': 'Zhejiang University'}}}}