SOX4 in HCC: The Mechanism of Sox4 Transcription in Regulation of Angiogenesis in Hepatocellular Carcinoma

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04296058

Collaborator

Ministry of Science and Technology, Taiwan (Other)

200

Enrollment

146.7

Actual Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Translational Research of SOX4 in Hepatocellular Carcinoma	Other: microvessel density

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 Design

Study Type:

Observational

Actual Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

SOX4 Activates CXCL12 in Hepatocellular Carcinoma Cells to Modulate Endothelial Cell Migration and Angiogenesis in Vivo

Actual Study Start Date :

Jan 8, 2007

Actual Primary Completion Date :

Mar 31, 2019

Actual Study Completion Date :

Mar 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
SOX4 high Nuclear expression of SOX4 over 90% in tumor specimen was defined as SOX4 high group	Other: microvessel density the vessel numbers in high power field with Anti-CD31 staining in tumor specimen
SOX4 low Nuclear expression of SOX4 less than 90% in tumor specimen was defined as SOX4 low group	Other: microvessel density the vessel numbers in high power field with Anti-CD31 staining in tumor specimen

Arm

Intervention/Treatment

SOX4 high

Nuclear expression of SOX4 over 90% in tumor specimen was defined as SOX4 high group

Other: microvessel density

the vessel numbers in high power field with Anti-CD31 staining in tumor specimen

SOX4 low

Nuclear expression of SOX4 less than 90% in tumor specimen was defined as SOX4 low group

Other: microvessel density

the vessel numbers in high power field with Anti-CD31 staining in tumor specimen

Outcome Measures

Primary Outcome Measures

Disease free survival (DFS) [a month]
The length of time from curative hepatectomies and recurrence or mortality

Secondary Outcome Measures

Overall survival [a month]
The length of time from curative hepatectomies and still alive

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

subjects with pathologic diagnosis of hepatocellular carcinoma and curative partial hepatectomies -

Exclusion Criteria:

history of different malignant disease, subject cannot be treated with curative surgery -

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Chang Gung Memorial Hospital
Ministry of Science and Technology, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chang Gung Memorial Hospital

ClinicalTrials.gov Identifier:

NCT04296058

Other Study ID Numbers:

106-2314-B-182A-113
103-2314-B-182A-082-MY1-3
106-2314-B-182A-113
CMRPD1G0611
CMRPD1H0661
CMRPG1J0061

First Posted:

Mar 5, 2020

Last Update Posted:

Mar 5, 2020

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Chang Gung Memorial Hospital

SOX4

angiogenesis

microvessel density

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Mar 5, 2020