Neutrophil Extracellular Traps as a Biomarker to Predict Portal Vein Tumor Thrombosis in Patients With Hepatocellular Carcinoma

Completed

• Conditions: Portal Vein Tumor Thrombosis; Neutrophil Extracellular Trap Formation
• Interventions: Other: test NETs markers

• Registration Number: NCT05040347
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief Summary

The aim of this study was to investigate whether NETs markers can enhance predict portal vein tumor thrombosis in patients with live cirrhosis, so as to establish a novel predictor to guide clinical decision-making.

Detailed Description

Eighty-six patients with patients treated at the Affiliated Hospital of Qingdao University (China) from September 2020 to January 2021 were recruited for this study, including 14 patients with portal vein tumor thrombosis, 28 patients without portal vein tumor thrombosis and 44 patients without hepatocellular carcinoma. NETs markers (Myeloperoxidase, Neutrophil elastase, Citrate histone H3), and anti-β2 glycoprotein I were detected in plasma using capture ELISA and specific ELISA kits. T-test was performed to analyze whether there was a statistical difference between the two groups, and regression analysis was performed between NETs markers and tissue factor and anti-β2 glycoprotein I to investigate whether there was a correlation. This study without any intervention measures, will not cause harm.

Study Timeline

• Study Start: 2020-08-18
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Status Verified: 2021-09
• Study First Submitted: 2021-09-02
• Study First Submitted QC: 2021-09-02
• Last Update Submitted: 2021-09-02
• Study First Posted: 2021-09-10
• Last Update Posted: 2021-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

（1) Clinical diagnosis of HCC with liver cirhosis (2) Clinical diagnosis of portal vein tumor thrombosis

Exclusion Criteria

(1) secondary liver malignancy (2)hematologic diseases (3) Bud-Chiah syndrome (4) incomplete data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCC group	test NETs markers	The diagnosis of HCC was confirmed by clinical correlation using histologic features taken from liver biopsy as determined by a pathologist,and findings from image studies including ultrasound, computed tomography, and MRI, verified by a radiologist.
PVTT group	test NETs markers	The diagnosis of portal vein tumor thrombosis was confirmed by clinical correlation using histologic features taken from liver biopsy as determined by a pathologist,and findings from image studies including ultrasound, computed tomography, and MRI, verified by a radiologist.
control group	test NETs markers	The presence of PVTT or HCC was confirmed by medical record review and all the recorded events were confirmed by a radiologist using imaging studies, ultrasound, contrast-enhanced, or MR.

Primary Outcome Measures

Name	Time	Method
Concentration of NETs markers and anti-β2 glycoprotein I	1 year.	NETs markers (Myeloperoxidase, Neutrophil elastase, Citrate histone H3) and anti-β2 glycoprotein I were detected in plasma using capture ELISA and specific ELISA kits.

Trial Locations

Locations (1)

the Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China