mSEPT9 biomarker to predict liver cancer in people with cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter cohort study enrolling 400 adults with confirmed cirrhosis and no existing HCC. Participants will be followed every six months for up to five years, with blood samples collected to measure mSEPT9 levels and standard clinical assessments. The goal is to see if changes from triple-negative to positive mSEPT9 status are associated with later HCC occurrence, and to explore differences by cirrhosis cause. Findings could support personalized surveillance by using mSEPT9 to identify higher-risk patients who may benefit from closer monitoring.

Why it matters

Who can join: the full rules

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.

Where it's running

• Regional and University Hospital Center of Nancy
  Vandœuvre-lès-Nancy, France Recruiting

Study contacts

• Study coordinator: Prof. Abderrahim OUSSALAH, MD, PhD
• Email: abderrahim.oussalah@univ-lorraine.fr
• Phone: +33383153629

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.