mSEPT9 Biomarker for Predicting Hepatocellular Carcinoma Occurrence in Patients With Cirrhosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Circulating mSEPT9 Biomarker Testing
Treatment groups
400 Participants
are divided into 1 treatment groupSponsors and collaborators
Central Hospital, Nancy, France
Lead sponsor
New Day Diagnostics
Collaborator
Source ClinicalTrials.gov