Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-26 @ 9:08 AM
Study NCT ID:
NCT00679692
Status:
COMPLETED
Last Update Posted:
2008-05-19
First Post:
2008-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation the Growth Factors(IGF-1,IGFBP-3and HGH)in Patients With Chronic Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-01', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-16', 'studyFirstSubmitDate': '2008-05-15', 'studyFirstSubmitQcDate': '2008-05-16', 'lastUpdatePostDateStruct': {'date': '2008-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['GH,IGF-1, IGFBP-3'], 'conditions': ['Hepatitis', 'Liver Cirrhosis', 'Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'BACKGROUND The insulin-like growth factor system (IGFs) plays an important role in cell growth and differentiation. Nevertheless, the roles played by insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3) and human growth hormone (HGH) in the progression of chronic liver disease remain to be elucidated and investigated.\n\nMETHODS The subjects in the present study included 60 healthy controls, 30 hepatitis patients, 60 liver cirrhosis patients and 60 untreated hepatocellular carcinoma patients. Blood was drawn by venipuncture into Venoject tubes. To find the possible correlations between liver damage and IGFs, serum IGF-1, GH, IGFBP-3 concentration and related biochemical parameters were measured. We used immunoradiometric assay to determine the levels of IGF-1, HGH and IGFBP-3 in serum.', 'detailedDescription': 'healthy controls:one blood sample (7.5 cc) hepatitis: three blood samples, at admission, at 3rd and 7-10th day of admission liver cirrhosis: two blood samples, at 1-2 years interval (7.5 cc/each session) hepatocellular carcinoma: three blood samples, before, 1 day after and at the 7th day of transcatheter arterial chembolizatiom'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute hepatitis liver cirrhosis hepatocellular carcinoma', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Hepatocellular carcinoma\n* Must be primary Hepatocellular carcinoma and untreament\n\nExclusion Criteria:\n\n* treatment Hepatocellular carcinoma'}, 'identificationModule': {'nctId': 'NCT00679692', 'briefTitle': 'Evaluation the Growth Factors(IGF-1,IGFBP-3and HGH)in Patients With Chronic Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Insulin-Like Growth Factor-1,Insulin-Like Growth Factor Binding Protein-3 and Human Growth Hormone in Serum of Patients With Chronic Liver Disease and Possible Clinical Applications.', 'orgStudyIdInfo': {'id': 'KMUH-IRB-950123'}, 'secondaryIdInfos': [{'id': 'KMUH-IRB-950123'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '3:', 'description': 'three arms for study'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Division of Radio immunoassay lab,Department of Nuclear Medical University Hospital,No.100 Tzyou 1st Road', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'chiou m Lin, Ms', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaohsiung Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kaoshing Medical University Chung-Ho Memorial Hospital', 'oldOrganization': 'Kaoshing Medical University Chung-Ho Memorial Hospital'}}}}