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

NCT06718530 | Recruiting

• 1 other identifier: CRO-2024-42
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (4)

Centro di Riferimento Oncologico (CRO) di aviano-IRCCS

Aviano, Pordenone, 33081, Italy

RECRUITING

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

Caserta, Italy

RECRUITING

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

Napoli, 80131, Italy

RECRUITING

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

Trieste, Italy

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Valli De Re, PhD

  Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS

  PRINCIPAL INVESTIGATOR

• Renato Cannizzaro, MD

  Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valli De Re, PhD

CONTACT

+39 0434 659672; vdere@cro.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: May 13, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

IT (4)