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

RECRUITINGSponsored by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Actively Recruiting
SponsorAzienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Started2023-02-24
Est. completion2024-06-27
Eligibility
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05781568

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

Healthy volunteers accepted
Inclusion Criteria:

1. Case Group:

   * Patients with HCC first diagnosed from cirrhosis or other aetiology
2. Controls group:

   * Candidate patients for HCC surveillance, with liver cirrhosis and chronic hepatitis of any etiology without HCC seen at our institution

Exclusion Criteria:

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

Conditions6

Cirrhosis, LiverHBVHCCHCVLiver DiseaseNAFLD

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