Hepatitis C Virus InfectionVERYMARKERSNCT06718530
Characterization of Immune Genotypes and Antibody Profiles to Foster the discoVERY of diagnosticbioMARKERS of Liver Cancer Development
An observational study of Hepatitis C Virus Infection, run by Centro di Riferimento Oncologico - Aviano at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus Infection
- How many people
- 1,000 participants
- Where
- 4 sitesItaly
- Study dates
- 13 May 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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 join
- Treatment for other oncological diseases
- Immunodepression congenital or acquired (HIV, organ transplantation, pharmacological)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 4 recruiting
- Recruiting
Centro di Riferimento Oncologico (CRO) di aviano-IRCCS
Aviano, Pordenone, 33081
Valli De Re, PhD, +39 0434 659672, vdere@cro.it
- Recruiting
AORN S.Anna e S. Sebastiano, Via F. Palasciano
Caserta
Arnolfo Petruzziello, +39 0823 232764, patologiaclinica.dir@ospedale.caserta.it
- Recruiting
Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale"
Naples, 80131
Maria Lina Tornesello, +39 081 17770588, m.tornesello@istitutotumori.na.it
- Recruiting
Dip. Univ. Clin. di Scienze mediche, chirurgiche e della salute Università di Trieste
Trieste
a Saveria Lory Crocè, MD, +39 040 3992925, saveria.croce@asugi.sanita.fvg.it
About this study
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
- Medical subject headings
- Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in antibody profile between subjects with and without chronic HCV infection
Mean or median difference between the groups, as appropriate, will be calculated
Measured: 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
Measured: 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
Correlation coefficient between the highest IgG levels towards at least one specific HCV peptide and high viral load will be calculated
Measured: up to 2 years
Define a relationship between IgG levels toward HCV-specific peptides and HCV genotype
Relation will be analyzed with logistic regression analysis and represented with Odds Ratio (OR) and relative 95% Confidence Interval (95% CI)
Measured: 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)
Frequencies of genetic variants within patient with or without HCV related hepatocarcinoma (HCC) will be reported
Measured: up to 2 years
Characterization of INFL4 and HLA-E variants within patient with or without HCV related chronic hepatitis
Frequencies of genetic variants within patient with or without HCV related chronic hepatitis will be reported
Measured: up to 2 years
Define the mRNA pathways activated in the subjects with expression of INFL4 and of HLA-E
Data will be illustrated with volcano plot and heat map
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start13 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valli De Re, PhD, Principal investigator, Centro di Riferimento Oncologico di Aviano (CRO) - IRCCSRenato Cannizzaro, MD, Principal investigator, Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718530
- Sponsor's protocol ID
- CRO-2024-42
- Acronym
- VERYMARKERS
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Immune Genotypes and Antibody Profiles to Foster the discoVERY of diagnosticbioMARKERS of Liver Cancer Development
- ClinicalTrials.gov ID
- NCT06718530
- Acronym / sponsor ID
- VERYMARKERS / CRO-2024-42
- Conditions
- Hepatitis C Virus Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Treatment for other oncological diseases
- Immunodepression congenital or acquired (HIV, organ transplantation, pharmacological)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in antibody profile between subjects with and without chronic HCV infection
Time frame: up to 2 years
Mean or median difference between the groups, as appropriate, will be calculated
Difference in antibody profile between subjects with chronic HCV infection receiving or not receiving DAA therapy
Time frame: up to 2 years
Mean or median difference between the groups, as appropriate, will be calculated
5 secondary outcomes
Define a relationship between IgG levels toward HCV-specific peptides and viral load/development clinical after 2 years of follow-up
Time frame: up to 2 years
Define a relationship between IgG levels toward HCV-specific peptides and HCV genotype
Time frame: 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)
Time frame: up to 2 years
Characterization of INFL4 and HLA-E variants within patient with or without HCV related chronic hepatitis
Time frame: up to 2 years
Define the mRNA pathways activated in the subjects with expression of INFL4 and of HLA-E
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valli De Re, PhD principal investigator
Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
Renato Cannizzaro, MD principal investigator
Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus Infection, run by Centro di Riferimento Oncologico - Aviano at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valli De Re, PhD (+39 0434 659672, vdere@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in antibody profile between subjects with and without chronic HCV infection (time frame: up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.