RecruitingNCT05781568

Use of Blood Biomarkers for the Early Diagnosis of Hepatocellular Carcinoma (HCC)

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Enrollment

60 participants

Start Date

Feb 24, 2023

Study Type

OBSERVATIONAL

Conditions

Cirrhosis, Liver HCC HBV HCV NAFLD

Summary

The objective of this observational study is to evaluate the clinical utility of the combined assay of 3 biomarkers: α-FP, α-FP-L3 and DCP (simultaneously measured by µTASWakoTM i30 automated in vitro diagnostic system) in high-risk subjects to develop this neoplasm. In particular, it aims to: * Evaluate the clinical utility of the combined use of α-FP, α-FP-L3 and DCP in predicting the onset of HEPATOCARCINOMA (HCC); * Evaluate the performance of GALAD and GALADUS scores in the early diagnosis of HCC; * Evaluate the association between the levels of the three biomarkers (individually and in combination with each other) and the stage of HCC

Eligibility

Inclusion Criteria4

Case Group:
Patients with HCC first diagnosed from cirrhosis or other aetiology
Controls group:
Candidate patients for HCC surveillance, with liver cirrhosis and chronic hepatitis of any etiology without HCC seen at our institution

Exclusion Criteria1

Patients treated with Warfarin, an anticoagulant, as it can increase DCP levels in the absence of HCC, risking giving false positives

Interventions

DIAGNOSTIC_TESTBiomarker dosage

The simultaneous dosage of the 3 serum biomarkers will be performed at the Clinical Pathology Laboratory, using the instrument: µTASWakoTM i30 (Micro Total Analysis System) - Fujifilm.