Identifying biomarkers for liver cancer in patients with Hepatitis C
Characterization of Immune Genotypes and Antibody Profiles to Foster the discoVERY of diagnosticbioMARKERS of Liver Cancer Development
This study is trying to find specific markers in the blood of people with chronic Hepatitis C to see if they can help spot liver cancer early.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro di Riferimento Oncologico - Aviano Academic / other |
| Locations | 4 sites (Aviano, Pordenone and 3 other locations) |
| Trial ID | NCT06718530 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize immune genotypes and antibody profiles in patients with chronic Hepatitis C virus (HCV) infection. It focuses on evaluating novel circulating biomarkers, including antibodies to specific HCV proteome peptides and the expression of interferon lambda 4 (IFNL4). The study will assess the genetic diversity of immune response markers that may predict the development of hepatocellular carcinoma (HCC) years before diagnosis. By understanding these biomarkers, the research seeks to improve surveillance and early detection of liver cancer in at-risk populations.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with chronic Hepatitis C infection, fibrosis, cirrhosis, or HCV-associated HCC.
Not a fit: Patients undergoing treatment for other oncological diseases or those with immunodepression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and better management of liver cancer in patients with Hepatitis C.
How similar studies have performed: Other studies have shown promise in identifying biomarkers for liver cancer, but this approach focusing on specific immune responses is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Aviano, Pordenone and 3 other locations
- Centro di Riferimento Oncologico (CRO) di aviano-IRCCS — Aviano, Pordenone, Italy (Recruiting)
- AORN S.Anna e S. Sebastiano, Via F. Palasciano — Caserta, Italy (Recruiting)
- Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale" — Naples, Italy (Recruiting)
- Dip. Univ. Clin. di Scienze mediche, chirurgiche e della salute Università di Trieste — Trieste, Italy (Recruiting)
Study contacts
- Principal investigator: Valli De Re, PhD — Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
- Study coordinator: Valli De Re, PhD
- Email: vdere@cro.it
- Phone: +39 0434 659672
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.