Studying blood markers to detect liver cancer early in hepatitis C patients
Studies blood markers that may help find liver cancer early in people with hepatitis C.
Key facts
- Who runs it
- Centro di Riferimento Oncologico - Aviano
- Where
- Aviano, Caserta, Naples, and Trieste, ItalySee the 4 sites
- Trial code
- Registry title
- Characterization of Immune Genotypes and Antibody Profiles to Foster the discoVERY of diagnosticbioMARKERS of Liver Cancer Development
- Status
- Recruiting
- People taking part
- 1,000 people, planned
- Started
- 13 May 2024
- Expected to end
- 31 Dec 2026
- Type of study
- Observational
- Record updated
- 5 December 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with hepatitis C virus (HCV) who have chronic infection, liver scarring, cirrhosis or liver cancer linked to HCV. It studies blood markers that may help find liver cancer early.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Chronic HCV infection, fibrosis, cirrhosis or HCV-associated liver cancer (HCC).
- Earlier treatment
- People having treatment for other cancers cannot join.
Main reasons for not taking part
- Treatment for other cancers
- Weak immune system from birth or acquired later (HIV, organ transplant, medicines)
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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
Who cannot take part
- Treatment for other oncological diseases
- Immunodepression congenital or acquired (HIV, organ transplantation, pharmacological)
Where in Italy
- Centro di Riferimento Oncologico (CRO) di Aviano - IRCCSAviano, ItalyContact: Valli De Re, PhDTaking people
- AORN S.Anna e S. Sebastiano, Via F. PalascianoCaserta, ItalyContact: Arnolfo PetruzzielloTaking people
- Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale"Naples, ItalyContact: Maria Lina TorneselloTaking people
- Dip. Univ. Clin. di Scienze mediche, chirurgiche e della salute Università di TriesteTrieste, ItalyContact: a Saveria Lory Crocè, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Characterization of Immune Genotypes and Antibody Profiles to Foster the discoVERY of diagnosticbioMARKERS of Liver Cancer Development
- Plain-language title
- Studying blood markers to detect liver cancer early in hepatitis C patientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 December 2024