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Recruiting NCT06718530

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

— Observational Hepatitis C Virus Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hepatitis C Virus Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Difference in antibody profile between subjects with and without chronic HCV infection [Time frame: up to 2 years]
  • Difference in antibody profile between subjects with chronic HCV infection receiving or not receiving DAA therapy [Time frame: up to 2 years]
Secondary outcome measures (5)
  • Define a relationship between IgG levels toward HCV-specific peptides and viral load/development clinical after 2 years of follow-up [Time frame: up to 2 years]
  • Define a relationship between IgG levels toward HCV-specific peptides and HCV genotype [Time frame: up to 2 years]
  • Characterization of Interferon Lambda 4 (INFL4) and Human Leukocyte antigene (HLA-E) variants within patient with or without HCV related hepatocarcinoma (HCC) [Time frame: up to 2 years]
  • Characterization of INFL4 and HLA-E variants within patient with or without HCV related chronic hepatitis [Time frame: up to 2 years]
  • Define the mRNA pathways activated in the subjects with expression of INFL4 and of HLA-E [Time frame: up to 2 years]

Eligibility criteria

Inclusion criteria

  • Patients aged ≥18 years with the presence of chronic infection, fibrosis, cirrhosis or HCV- associated HCC
  • Patients able to understand and willing to sign the of informed consent
  • Patients to answer the questions in the questionnaire of enrollment

Exclusion criteria

  • Treatment for other oncological diseases
  • Immunodepression congenital or acquired (HIV, organ transplantation, pharmacological)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 4 centers
  • Centro di Riferimento Oncologico (CRO) di aviano-IRCCS — Aviano
  • AORN S.Anna e S. Sebastiano, Via F. Palasciano — Caserta
  • Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale" — Naples
  • Dip. Univ. Clin. di Scienze mediche, chirurgiche e della salute Università di Trieste — Trieste

Identifiers

NCT: NCT06718530 · CRO-2024-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗