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RECRUITING
NCT06718530

Characterization of Immune Genotypes and Antibody Profiles to Foster the discoVERY of diagnosticbioMARKERS of Liver Cancer Development

Sponsor: Centro di Riferimento Oncologico - Aviano

View on ClinicalTrials.gov

Summary

Hepatitis C virus (HCV), which infects more than 185 million people, is a major risk factor. Direct-acting antiviral (DAA) therapy has significantly improved the eradication of the virus, but has not completely eliminated the risk of HCC, so careful surveillance is necessary. The genetic diversity of the natural killer receptor, histocompatibility antigens (HLA) and interferon lambda 4 (INFL4) activity, among other factors, have been found to be crucial in directing disease progression. Importantly, these markers are detectable years before the diagnosis of HCC. In addition, polymorphic variants attributable to the expression of genes involved in innate-type immune response, such as IFNL4 and HLA-E, have been shown to be predictive for the development of HCC and have not yet been extensively studied. The aim of the study is to evaluate novel circulating biomarkers, including the presence of antibodies to specific HCV proteome peptides, IFNL4 expression, and the interaction of specific HLA receptors/ligands in a large cohort of HCV-positive subjects in order to create a screening strategy for the early diagnosis of HCV-associated HCC. Part of the study will be devoted to describing the immune microenvironment associated with the expression of IFNL4 and HLAE, evaluating them as potential prognostic indicators for HCC in HCV-infected subjects undergoing surgery for HCC, as well as in those with advanced/metastatic HCC.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2024-05-13

Completion Date

2026-12-31

Last Updated

2024-12-05

Healthy Volunteers

No

Locations (4)

Centro di Riferimento Oncologico (CRO) di aviano-IRCCS

Aviano, Pordenone, Italy

AORN S.Anna e S. Sebastiano, Via F. Palasciano

Caserta, Italy

Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale"

Naples, Italy

Dip. Univ. Clin. di Scienze mediche, chirurgiche e della salute Università di Trieste

Trieste, Italy