Viewing Study NCT04296058


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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: Chang Gung Memorial Hospital
Organization:

Study Overview

Official Title: SOX4 Activates CXCL12 in Hepatocellular Carcinoma Cells to Modulate Endothelial Cell Migration and Angiogenesis in Vivo
Status: COMPLETED
Status Verified Date: 2019-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SOX4 in HCC
Brief Summary: 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
Detailed Description: 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).

Cox 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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
103-2314-B-182A-082-MY1-3 OTHER_GRANT MOST View
106-2314-B-182A-113 OTHER_GRANT MOST View
CMRPD1G0611 OTHER_GRANT Chang Gung medical foundation View
CMRPD1H0661 OTHER_GRANT Chang Gung medical foundation View
CMRPG1J0061 OTHER_GRANT Chang Gung medical foundation View