Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-01-01 @ 10:58 AM
Study NCT ID:
NCT00769535
Status:
COMPLETED
Last Update Posted:
2013-04-30
First Post:
2008-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Polymorphism of Heat Shock Protein 70 Gene and Hepatocellular Carcinoma
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-26', 'studyFirstSubmitDate': '2008-02-26', 'studyFirstSubmitQcDate': '2008-10-07', 'lastUpdatePostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical relevance', 'timeFrame': 'year'}], 'secondaryOutcomes': [{'measure': 'Clinical relevance', 'timeFrame': 'year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['heat shock protein70', 'tumor necrosis factor-alpha promoter', 'polymorphism'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Polymorphisms of HSP70 and tumor necrosis factor-alpha promoter in patients with hepatocellular carcinoma, chronic liver disease and healthy controls will be measured by PCR-RFLP or direct sequencing. The clinical relevance of patients will be compared in those with polymorphism and those without.', 'detailedDescription': 'Heat shock protein 70 (HSP 70) may be involved in various aspects of immune system including infection, autoimmunity, and tumor immunity. The relationship between HSP70 expression, disease activity and cancer prognosis varied according to type of cancer. The overexpression of HSP70 by tumor cells contributes to tumor behavior. HSP70 is present in normal and abnormal hepatocytes, and was reported to be over-expressed in both hepatoma cell lines and human hepatocellular carcinoma (HCC) tissue. Recent study indicated that HSP70 is a molecular marker during early hepatocarcinogenesis. It is also involved in anti-tumor immunity in HCC.We also investigate the polymorphism of tumor necrosis factor-alpha promoter, and correlated to clinical relevance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History proven HCC patients\n\nExclusion Criteria:\n\n* No-definite diagnosed patients'}, 'identificationModule': {'nctId': 'NCT00769535', 'acronym': 'HSP70', 'briefTitle': 'Relationship Between Polymorphism of Heat Shock Protein 70 Gene and Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Relationship Between Polymorphism of Heat Shock Protein 70 Gene and Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'KMUH-IRB-930047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HSP70 and TNF polymorphisms', 'interventionNames': ['Genetic: Polymorphisms of HSP70 and TNF promoter']}], 'interventions': [{'name': 'Polymorphisms of HSP70 and TNF promoter', 'type': 'GENETIC', 'otherNames': ['polymorphism of HSP70', 'polymorphism of tumor necrosis factor-alpha promoter'], 'description': 'To assess the relationship between clinical relevance and polymorphisms of HSP70 and tumor necrosis factor-alpha with PCR\\_RFLP', 'armGroupLabels': ['HSP70 and TNF polymorphisms']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'state': 'Kaohsiung', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '807', 'city': 'Kaohsiung City', 'state': 'Kaohsiun', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Jung-Fa Tsai, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}