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

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.

Study Overview

• Status: Completed
• Conditions: Portal Vein Tumor Thrombosis; Neutrophil Extracellular Trap Formation
• Intervention / Treatment: Other: test NETs markers

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 Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China
      • The Affiliated Hospital of Qingdao University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PVTT group; 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.	Other: test NETs markers; NETs markers (Myeloperoxidase, Neutrophil elastase, Citrate histone H3) and anti-β2 glycoprotein I were detected in plasma using capture ELISA and specific ELISA kits.
HCC group; 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.	Other: test NETs markers; NETs markers (Myeloperoxidase, Neutrophil elastase, Citrate histone H3) and anti-β2 glycoprotein I were detected in plasma using capture ELISA and specific ELISA kits.
control group; 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.	Other: test NETs markers; NETs markers (Myeloperoxidase, Neutrophil elastase, Citrate histone H3) and anti-β2 glycoprotein I were detected in plasma using capture ELISA and specific ELISA kits.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2020
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: September 2, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 10, 2021

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Neutrophil Extracellular Trap; Portal Vein Tumor Thrombosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Embolism and Thrombosis; Liver Neoplasms; Carcinoma, Hepatocellular; Thrombosis
• Other Study ID Numbers: QYFYWZLL26511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No