Brief Summary

This study aims to evaluate the role of the circulating epigenetic biomarker mSEPT9 in predicting the risk of hepatocellular carcinoma (HCC) in patients with cirrhosis. HCC is a primary liver cancer that frequently develops in individuals with cirrhosis, and early detection is critical for improving outcomes. This research involves 400 patients with cirrhosis who will be followed every six months for up to 60 months. During these visits, blood samples will be collected to analyze mSEPT9 levels. By identifying changes in this biomarker, the study seeks to improve early diagnosis and personalize surveillance strategies, potentially enhancing patient survival and quality of life.

Conditions

• Hepatocellular Carcinoma (HCC)
• Cirrhosis
• Risk Prediction for Liver Cancer
• Epigenomics

Intervention / Treatment

• Diagnostic Test: Circulating mSEPT9 Biomarker Testing

Primary Outcome Measures

• Association Between mSEPT9 Test Switch and Hepatocellular Carcinoma (HCC) Development (Annually for up to 60 months or until the occurrence of HCC, whichever occurs first.)
  Evaluate the relationship between a 'switch' in the mSEPT9 test result-defined as a transition from triple-negative (no methylation detected across all triplicates) to at least one positive triplicate-and the occurrence of hepatocellular carcinoma (HCC), as diagnosed using international criteria established by the AASLD.

Countries

France

Locations and Investigators

• Regional and University Hospital Center of Nancy, Vandœuvre-lès-Nancy, France (Recruiting)
  • Prof. Abderrahim OUSSALAH, MD, PhD

Study Officials

• Mr. Franck Schreiner (Study Director) — Regional and University Hospital Center of Nancy