NCT05781568: GALAD

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

Recruiting now Last updated 8 April 2024

What this trial tests

trial testing Biomarker dosage in HCC in 60 participants. Currently enrolling.

Timeline

24 February 2023

Primary endpoint
27 June 2024

27 January 2025

Quick facts

Lead sponsor	Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	60
Start date	24 February 2023
Primary completion	27 June 2024
Estimated completion	27 January 2025
Sites	1 location across Italy

Drugs / interventions tested

• Biomarker dosage

Conditions studied

• HCC — all drugs for HCC →
• Cirrhosis, Liver — all drugs for Cirrhosis, Liver →
• NAFLD — all drugs for NAFLD →
• HBV — all drugs for HBV →

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Who can join

Eligibility, any sex, with HCC or Cirrhosis, Liver. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Insights into the GALAD score: A new optimal cut-off for hepatocellular carcinoma.
   Villa E, Donghia R, Coletta S, Bonfiglio C, et al · · 2025 · cited 1× · PMID 41180985 · DOI 10.3748/wjg.v31.i40.111727