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

NCT ID: NCT06718530

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-13

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C Virus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro di Riferimento Oncologico - Aviano

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valli De Re, PhD

Role: PRINCIPAL_INVESTIGATOR

Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS

Renato Cannizzaro, MD

Role: PRINCIPAL_INVESTIGATOR

Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS

Locations

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Centro di Riferimento Oncologico (CRO) di aviano-IRCCS

Aviano, Pordenone, Italy

Site Status RECRUITING

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

Caserta, , Italy

Site Status RECRUITING

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

Napoli, , Italy

Site Status RECRUITING

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

Trieste, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Valli De Re, PhD

Role: CONTACT

Phone: +39 0434 659672

Email: [email protected]

Facility Contacts

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Valli De Re, PhD

Role: primary

Arnolfo Petruzziello

Role: primary

Maria Lina Tornesello

Role: primary

a Saveria Lory Crocè, MD

Role: primary

Other Identifiers

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CRO-2024-42

Identifier Type: -

Identifier Source: org_study_id