Clinical Research Directory
Browse clinical research sites, groups, and studies.
Characterization of Immune Genotypes and Antibody Profiles to Foster the discoVERY of diagnosticbioMARKERS of Liver Cancer Development
Sponsor: Centro di Riferimento Oncologico - Aviano
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
Conditions
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