mSEPT9 Biomarker for Predicting Hepatocellular Carcinoma Occurrence in Patients With Cirrhosis

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.

Inclusion Criteria: * Adults aged 18 years or older. * Patients diagnosed with cirrhosis confirmed by clinical, biochemical, radiological, or histological criteria. * Cirrhosis attributable to one or more of the following etiologies: alcohol, hepatitis C (HCV), hepatitis B (HBV), nonalcoholic steatohepatitis (NASH), hemochromatosis, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, or cryptogenic causes. * Patients actively followed in one of the participating study centers. * Patients affiliated with a social security program or equivalent. * Patients with a body weight greater than 45 kg. * Patients who have been fully informed about the study procedures and have provided oral informed consent. Exclusion Criteria: * History of hepatocellular carcinoma (HCC). * History of any other primary or secondary malignant liver tumor. * Diagnosis of malignancy or hematologic disorders within the past 5 years (without time limitation for hematologic malignancies). * Patients currently undergoing hemodialysis. * Pregnant or breastfeeding women. * Individuals under legal protection (e.g., guardianship, curatorship) or unable to provide consent. * Minors or individuals younger than 18 years. * Individuals deprived of liberty by judicial or administrative order. * Patients with psychiatric conditions receiving care under legal constraints (e.g., articles L.3212-1 and L.3213-1). * Patients unable to comply with the study protocol requirements.