NCT06718530|Recruiting
Characterization of Immune Genotypes and Antibody Profiles to Foster the discoVERY of diagnosticbioMARKERS of Liver Cancer Development
VERYMARKERS
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VERYMARKERS
Sponsor study identifier
observational
1,000
1 country
4
Study Start
May 13, 2024
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 13, 2024
Actual (reported)December 2, 2024
Actual (reported)December 5, 2024
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Difference in antibody profile between subjects with and without chronic HCV infection
Mean or median difference between the groups, as appropriate, will be calculated
up to 2 years
Difference in antibody profile between subjects with chronic HCV infection receiving or not receiving DAA therapy
Mean or median difference between the groups, as appropriate, will be calculated
up to 2 years
Define a relationship between IgG levels toward HCV-specific peptides and viral load/development clinical after 2 years of follow-up
up to 2 years
Define a relationship between IgG levels toward HCV-specific peptides and HCV genotype
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)
up to 2 years
Characterization of INFL4 and HLA-E variants within patient with or without HCV related chronic hepatitis
up to 2 years
Define the mRNA pathways activated in the subjects with expression of INFL4 and of HLA-E
up to 2 years
The study population consists of patients with varying degrees of liver damage, diagnosed with of HCC or HCV-positive with diagnosed cirrhosis, fibrosis or long-term HCV infection
Centro di Riferimento Oncologico (CRO) di aviano-IRCCS
Aviano, Pordenone, 33081, Italy
AORN S.Anna e S. Sebastiano, Via F. Palasciano
Caserta, Italy
Valli De Re, PhD
Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
Renato Cannizzaro, MD
Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
First Submitted
December 2, 2024
First Posted
December 5, 2024
Study Start
May 13, 2024
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Relinking Diagnosed But Untreated HCV Patients Back Into Care.
Contact the study team to confirm eligibility.
Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale"
Naples, 80131, Italy
Dip. Univ. Clin. di Scienze mediche, chirurgiche e della salute Università di Trieste
Trieste, Italy
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 5, 2024
Record last verified: 2024-12
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