Viewing Study NCT01237132


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Study NCT ID: NCT01237132
Status: COMPLETED
Last Update Posted: 2010-11-09
First Post: 2010-11-08
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: East-West Hepatocellular Carcinoma Study Group
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': 'COHORT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'lastUpdateSubmitDate': '2010-11-08', 'studyFirstSubmitDate': '2010-11-08', 'studyFirstSubmitQcDate': '2010-11-08', 'lastUpdatePostDateStruct': {'date': '2010-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival of resected patients for HCC', 'description': 'The primary endpoint of the study was the overall survival of patients resected for HCC in any stage of the BCLC classification.'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival of resected patients for HCC', 'description': 'The secondary endpoint was the disease-free survival of patients resected for HCC among the BCLC stages.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Carcinoma, Hepatocellular']}, 'descriptionModule': {'briefSummary': 'The current treatment guidelines of hepatocellular carcinoma (HCC) of the American and European Associations for the Study of Liver Disease are based on the Barcelona-Clinic-Liver-Cancer classification (BCLC), which does not recommend surgery in patients with large, multinodular and macrovascular invasive disease. The aim of this study was to investigate the role of hepatic resection in a large retrospective multicentric cohort of patients resected for HCC regardless of the BCLC indications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients affected by HCC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of hepatocellular carcinoma\n* candidate to liver resection as a curative treatment\n\nExclusion Criteria:\n\n* uncertain diagnosis of hepatocellular carcinoma\n* uncertain follow-up data'}, 'identificationModule': {'nctId': 'NCT01237132', 'briefTitle': 'East-West Hepatocellular Carcinoma Study Group', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'EAST-WEST HEPATOCELLULAR CARCINOMA STUDY GROUP', 'orgStudyIdInfo': {'id': 'HCC EWE'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'GUIDO TORZILLI MD, PHD', 'oldOrganization': 'UNIVERSITY OF MILAN'}}}}