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

March 3, 2020 updated by: Chang Gung Memorial Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

subjects with pathologic diagnosis of hepatocellular carcinoma

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival (DFS)
Time Frame: a month
The length of time from curative hepatectomies and recurrence or mortality
a month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: a month
The length of time from curative hepatectomies and still alive
a month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

Ministry of Science and Technology, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2007

Primary Completion (Actual)

March 31, 2019

Study Completion (Actual)

March 31, 2019

Study Registration Dates

First Submitted

March 3, 2020

First Submitted That Met QC Criteria

March 3, 2020

First Posted (Actual)

March 5, 2020

Study Record Updates

Last Update Posted (Actual)

March 5, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106-2314-B-182A-113 (Other Grant/Funding Number: MOST)
  • 103-2314-B-182A-082-MY1-3 (Other Grant/Funding Number: MOST)
  • CMRPD1G0611 (Other Grant/Funding Number: Chang Gung medical foundation)
  • CMRPD1H0661 (Other Grant/Funding Number: Chang Gung medical foundation)
  • CMRPG1J0061 (Other Grant/Funding Number: Chang Gung medical foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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