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

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

Plain Language Summary

Simplified for easier understanding

This study is testing blood biomarkers (substances measurable in the blood) to see if they can detect liver cancer (hepatocellular carcinoma, or HCC) at an early stage — before it becomes visible on standard imaging. Early detection is critical for improving survival rates in liver cancer. **You may be eligible if:** - You are a patient newly diagnosed with liver cancer (HCC) arising from cirrhosis or another liver condition (case group), OR - You are a patient with liver cirrhosis or chronic hepatitis being monitored for liver cancer but without a current diagnosis (control group) **You may NOT be eligible if:** - You are currently taking warfarin (a blood thinner), as it can interfere with one of the blood markers being tested and produce misleading results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

RCCS "Saverio de Bellis"

Castellana Grotte, Bari, Italy

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NCT05781568


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