MSEPT9 Biomarker for Predicting Hepatocellular Carcinoma Occurrence in Patients with Cirrhosis

Launched by CENTRAL HOSPITAL, NANCY, FRANCE · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a blood test that looks for a specific biomarker called mSEPT9, which may help predict the risk of developing liver cancer, known as hepatocellular carcinoma (HCC), in patients who have cirrhosis. Cirrhosis is a serious liver condition that can lead to liver cancer, so finding ways to detect it early is very important for improving treatment outcomes. The study will involve 400 adults with cirrhosis, who will have their blood tested every six months for up to five years. By monitoring changes in the mSEPT9 levels, the researchers hope to enhance early diagnosis and tailor follow-up care for patients, potentially leading to better survival rates and quality of life.

To be eligible for this trial, participants must be at least 18 years old and diagnosed with cirrhosis for various reasons, such as alcohol use or viral hepatitis. They should also weigh more than 45 kg and be actively followed by a participating medical center. However, people with a history of liver cancer or certain other health issues, like being on dialysis or being pregnant, cannot join. Participants will be closely monitored throughout the study, and they will need to give their consent after understanding the study procedures. This trial aims to contribute valuable information that could help improve care for patients with cirrhosis.

Gender

ALL

Eligibility criteria

• 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.