Clinical trial · Observational
Characterization of Immune Genotypes and Antibody Profiles to Foster the discoVERY of diagnosticbioMARKERS of Liver Cancer Development
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatitis C Virus Infection | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Difference in antibody profile between subjects with and without chronic HCV infection
- timeFrame
- up to 2 years
- description
- Mean or median difference between the groups, as appropriate, will be calculated
- measure
- Difference in antibody profile between subjects with chronic HCV infection receiving or not receiving DAA therapy
- timeFrame
- up to 2 years
- description
- Mean or median difference between the groups, as appropriate, will be calculated
Secondary outcomes (5)
- measure
- Define a relationship between IgG levels toward HCV-specific peptides and viral load/development clinical after 2 years of follow-up
- timeFrame
- up to 2 years
- description
- Correlation coefficient between the highest IgG levels towards at least one specific HCV peptide and high viral load will be calculated
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available