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

NCT05040347 | Completed

• 1 other identifier: QYFYWZLL26511
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Neutrophil Extracellular Trap Formation; Portal Vein Tumor Thrombosis

Keywords

Neutrophil Extracellular Trap; Portal Vein Tumor Thrombosis

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

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

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

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

Interventions

test NETs markers OTHER

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; PVTT group; control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

the Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 10, 2021
• Study Start: August 18, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-09

Locations

CN (1)