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Completed

NCT Number: NCT04296058

The Mechanism of Sox4 Transcription in Regulation of Angiogenesis in Hepatocellular Carcinoma

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

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Key information

Conditions

Translational Research of SOX4 in Hepatocellular Carcinoma

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

microvessel density

Other

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

Primary outcomes

  1. Disease free survival (DFS)

    Time frame: a month

    The length of time from curative hepatectomies and recurrence or mortality

Secondary outcomes

  1. Overall survival

    Time frame: a month

    The length of time from curative hepatectomies and still alive

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • Ministry of Science and Technology, Taiwan

Registry information

Official study title

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

Acronym: SOX4 in HCC

Important dates

Study start
2007
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2020
Registry last updated
Mar 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.