Actively Recruiting
Characterization of Immune Genotypes and Antibody Profiles to Foster the discoVERY of diagnosticbioMARKERS of Liver Cancer Development
Led by Centro di Riferimento Oncologico - Aviano · Updated on 2024-12-05
1000
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Hepatitis C virus (HCV) infects over 185 million people worldwide and is a major risk factor for developing liver cancer called hepatocellular carcinoma (HCC). Although direct-acting antiviral (DAA) treatments have improved virus eradication, the risk of HCC remains, so careful monitoring is still needed. This research aims to evaluate new blood biomarkers, including antibodies to specific HCV proteins and genetic markers related to immune response, to help develop an early screening method for liver cancer in people with chronic HCV infection. The study will examine the presence of antibodies against HCV peptides, the expression of interferon lambda 4 (IFNL4), and interactions involving specific human leukocyte antigen (HLA) receptors. It will also study the immune environment linked to IFNL4 and HLA-E expression in patients undergoing surgery for HCC or those with advanced liver cancer. These evaluations will help understand the role of these immune markers in the progression of HCC in HCV-positive individuals. Participants will be followed for up to 2 years during which researchers will measure differences in antibody profiles between patients with and without chronic HCV infection and among those receiving or not receiving DAA therapy. The study will also assess relationships between antibody levels, viral load, HCV genotype, and immune gene variants. Data collected will include blood samples and questionnaire responses to monitor immune markers and disease progression over time.
CONDITIONS
Brief Title
Characterization of Immune Genotypes and Antibody Profiles to Foster the discoVERY of diagnosticbioMARKERS of Liver Cancer Development
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older with chronic HCV infection, liver fibrosis, cirrhosis, or HCV-associated hepatocellular carcinoma
- Patients able to understand and willing to sign the informed consent
- Patients willing to answer questions in the enrollment questionnaire
You will not qualify if you...
- Treatment for other oncological diseases
- Congenital or acquired immunodepression, including HIV, organ transplantation, or immunosuppressive drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants are observed over time to assess immune genotypes and antibody profiles related to liver cancer development.
Multiple visits over 2 years for assessments
Trial Site Locations
Total: 4 locations
1
Centro di Riferimento Oncologico (CRO) di aviano-IRCCS
Aviano, Pordenone, Italy, 33081
Actively Recruiting
2
AORN S.Anna e S. Sebastiano, Via F. Palasciano
Caserta, Italy
Actively Recruiting
3
Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale"
Naples, Italy, 80131
Actively Recruiting
4
Dip. Univ. Clin. di Scienze mediche, chirurgiche e della salute Università di Trieste
Trieste, Italy
Actively Recruiting
Research Team
V
Valli De Re, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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