Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT04296058
Status:
COMPLETED
Last Update Posted:
2020-03-05
First Post:
2020-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Mechanism of Sox4 Transcription in Regulation of Angiogenesis in Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082644', 'term': 'Microvascular Density'}], 'ancestors': [{'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-03', 'studyFirstSubmitDate': '2020-03-03', 'studyFirstSubmitQcDate': '2020-03-03', 'lastUpdatePostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease free survival (DFS)', 'timeFrame': 'a month', 'description': 'The length of time from curative hepatectomies and recurrence or mortality'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'a month', 'description': 'The length of time from curative hepatectomies and still alive'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SOX4', 'angiogenesis', 'microvessel density'], 'conditions': ['Translational Research of SOX4 in Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Two hundred HCC patients with partial hepatectomy were enrolled as a cohort for observational study. The inclusion criterion was intended curative hepatectomy for HCC patients by image analysis, and the exclusion criteria were unresectable disease, synchronous cancers, recurrent cancers, or distant metastasis. The study endpoint was 30 March 2019, and tumor staging was based on the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system for HCC', 'detailedDescription': 'To determine the role of SOX4 in tumor progression in patients with HCC, we examined SOX4 expression through immunohistochemistry (IHC) staining of 200 formalin-fixed and paraffin-embedded (FFPE) HCC specimens . The SOX4 high group of patients was associated with positive etiology of hepatitis B virus (P = 0.044), tumor size \\>5 cm (P = 0.014), thrombus formation (P = 0.012), higher microvessel density (MVD) (P = 0.012) in tumor lesions, and distant metastasis (P \\<0.001).\n\nCox regression analysis showed that patients with elderly age (P \\<0.001), higher ⍺-fetal protein (AFP) (P = 0.045), presence of cirrhosis (P = 0.008), and SOX4 high in tumor specimen (P = 0.042) were independent risk factors . The SOX4 high group performed significantly worse regarding overall survival (OS) (P = 0.043) and disease-free survival (DFS) (P = 0.019) based on the Kaplan-Meier analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'subjects with pathologic diagnosis of hepatocellular carcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nsubjects with pathologic diagnosis of hepatocellular carcinoma and curative partial hepatectomies -\n\nExclusion Criteria:\n\nhistory of different malignant disease, subject cannot be treated with curative surgery -'}, 'identificationModule': {'nctId': 'NCT04296058', 'acronym': 'SOX4 in HCC', 'briefTitle': 'The Mechanism of Sox4 Transcription in Regulation of Angiogenesis in Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'SOX4 Activates CXCL12 in Hepatocellular Carcinoma Cells to Modulate Endothelial Cell Migration and Angiogenesis in Vivo', 'orgStudyIdInfo': {'id': '106-2314-B-182A-113'}, 'secondaryIdInfos': [{'id': '103-2314-B-182A-082-MY1-3', 'type': 'OTHER_GRANT', 'domain': 'MOST'}, {'id': '106-2314-B-182A-113', 'type': 'OTHER_GRANT', 'domain': 'MOST'}, {'id': 'CMRPD1G0611', 'type': 'OTHER_GRANT', 'domain': 'Chang Gung medical foundation'}, {'id': 'CMRPD1H0661', 'type': 'OTHER_GRANT', 'domain': 'Chang Gung medical foundation'}, {'id': 'CMRPG1J0061', 'type': 'OTHER_GRANT', 'domain': 'Chang Gung medical foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'SOX4 high', 'description': 'Nuclear expression of SOX4 over 90% in tumor specimen was defined as SOX4 high group', 'interventionNames': ['Other: microvessel density']}, {'label': 'SOX4 low', 'description': 'Nuclear expression of SOX4 less than 90% in tumor specimen was defined as SOX4 low group', 'interventionNames': ['Other: microvessel density']}], 'interventions': [{'name': 'microvessel density', 'type': 'OTHER', 'description': 'the vessel numbers in high power field with Anti-CD31 staining in tumor specimen', 'armGroupLabels': ['SOX4 high', 'SOX4 low']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Science and Technology, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}