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RECRUITING
NCT05781568

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

Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2023-02-24

Completion Date

2025-01-27

Last Updated

2024-04-08

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Biomarker 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.

Locations (1)

RCCS "Saverio de Bellis"

Castellana Grotte, Bari, Italy