Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-22 @ 7:24 AM
Study NCT ID:
NCT03504358
Status:
COMPLETED
Last Update Posted:
2018-04-20
First Post:
2018-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A New Prognostic Scoring System for Spontaneous Ruptured Hepatocellular
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012422', 'term': 'Rupture, Spontaneous'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D006498', 'term': 'Hepatectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-12', 'studyFirstSubmitDate': '2018-04-04', 'studyFirstSubmitQcDate': '2018-04-12', 'lastUpdatePostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3 years', 'description': 'Overall survival after partial hepatectomy'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '3 years', 'description': 'Recurrence-free survival after partial hepatectomy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgery', 'scoring system', 'hepatocellular carcinoma', 'homogeneity and discriminatory ability', 'survival'], 'conditions': ['Rupture, Spontaneous']}, 'descriptionModule': {'briefSummary': 'Develop a new scoring system for HCC patients with tumor rupture.', 'detailedDescription': 'There has been no special prognostic scoring system for HCC patients with tumor rupture in the literature. In this work, we obtained all survival risk factors of ruptured HCC patients who underwent partial hepatectomy using multivariable Cox regression analysis. Furthermore, we develop and validate a new postoperative scoring system for patients with spontaneous HCC rupture based on the these results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ten year HCC rupture patients who received partial hepatectomy at Tongji Hospital of the Huazhong University of Science and Technology', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Received partial hepatectomy; with Child A or B liver function.\n\nExclusion Criteria:\n\n* Without complete data；loss of follow-up; had reveived repeated transcatheter arterial chemoembolization before rupture; received non-radical resection.'}, 'identificationModule': {'nctId': 'NCT03504358', 'briefTitle': 'A New Prognostic Scoring System for Spontaneous Ruptured Hepatocellular', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'A New Prognostic Scoring System for Spontaneous Ruptured Hepatocellular Carcinoma: A Retrospective Study', 'orgStudyIdInfo': {'id': 'Zhupeng002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Analysis before liver resection', 'description': 'Multivariate analysis of predictive factors associated with survival', 'interventionNames': ['Procedure: Liver resection']}, {'label': 'Different risk group', 'description': 'Low-risk group, moderate-risk group, high-risk group', 'interventionNames': ['Procedure: Liver resection']}, {'label': 'Model comparison', 'description': 'Comparison of models in predicting survival', 'interventionNames': ['Procedure: Liver resection']}], 'interventions': [{'name': 'Liver resection', 'type': 'PROCEDURE', 'description': 'Partial hepatectomy comprised single or multiple hepatic resections aiming at excising all visible malignant tissue.', 'armGroupLabels': ['Analysis before liver resection', 'Different risk group', 'Model comparison']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bi-xiang Zhang, Prof, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiaoping Chen', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}