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

NCT05781568 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2024-04-08

No results posted yet for this study

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

Conditions

  • HCC
  • Cirrhosis, Liver
  • NAFLD
  • HBV
  • HCV

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.

Sponsors & Collaborators

  • Dr. Raffaele Cozzolongo

    collaborator UNKNOWN

  • Dr. Palma Aurelia Iacovazzi

    collaborator UNKNOWN

  • Dr. Vito Giannuzzi

    collaborator UNKNOWN

  • Dr. Francesco Losito

    collaborator UNKNOWN

  • Dr. Marianna Zappimbulso

    collaborator UNKNOWN

  • Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

    lead OTHER

Principal Investigators

  • Endrit Shahini, MD · IRCCS "Saverio de Bellis" - Castellana Grotte (BA) - Italy

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-24
Primary Completion
2024-06-27
Completion
2025-01-27

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05781568 on ClinicalTrials.gov