Blood Test mSEPT9 to Predict Liver Cancer in Cirrhosis Patients
Tests a blood marker, mSEPT9, to predict liver cancer in adults with cirrhosis.
Key facts
- Who runs it
- Central Hospital, Nancy, France
- Where
- Vandœuvre-lès-Nancy, FranceSee the site
- Trial code
- Registry title
- mSEPT9 Biomarker for Predicting Hepatocellular Carcinoma Occurrence in Patients With Cirrhosis
- Status
- Recruiting
- People taking part
- 400 people, planned
- Started
- 3 Jun 2025
- Expected to end
- 3 Jun 2033
- Type of study
- Observational
- Treatments tested
- Circulating mSEPT9 Biomarker Testing
- Record updated
- 10 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with cirrhosis who are followed at a study center. Blood tests will check the mSEPT9 marker to predict liver cancer risk.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Cirrhosis confirmed by clinical, biochemical, radiological, or histological criteria. Causes can be alcohol, hepatitis C (HCV), hepatitis B (HBV), nonalcoholic steatohepatitis (NASH), hemochromatosis, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, or an unknown cause.
Main reasons for not taking part
- Past hepatocellular carcinoma (HCC) or any other primary or secondary malignant liver tumor
- Cancer or blood disorder diagnosed in the past 5 years
- Currently on hemodialysis
- Pregnant or breastfeeding
- Cannot give consent, or is under legal protection or deprived of liberty
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients with psychiatric conditions receiving care under legal constraints (e.g., articles L.3212-1 and L.3213-1)
- 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)
- Minors or individuals younger than 18 years
- Patients currently undergoing hemodialysis
- Pregnant or breastfeeding women
- Individuals under legal protection (e.g., guardianship, curatorship) or unable to provide consent
- Individuals deprived of liberty by judicial or administrative order
- Patients unable to comply with the study protocol requirements
Where in France
- Regional and University Hospital Center of NancyVandœuvre-lès-Nancy, FranceContact: Prof. Abderrahim OUSSALAH, MD, PhDTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Patients With Cirrhosis Without Hepatocellular Carcinoma at Baseline
This cohort includes 400 patients with cirrhosis who do not have hepatocellular carcinoma (HCC) at the time of inclusion. Participants will undergo standard clinical, biological, and radiological evaluations every six months for a total follow-up duration of 60 months, in accordance with international guidelines for cirrhosis management. In addition to routine assessments, blood samples will be collected at each visit for the analysis of the circulating epigenetic biomarker mSEPT9. This biomarker will be tested to evaluate its utility in predicting the occurrence of HCC during the follow-up period. The results of the mSEPT9 test will not influence clinical management during the study.
Treatment: Circulating mSEPT9 Biomarker Testing
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of the Circulating Epigenetic Biomarker mSEPT9 for Predicting the Occurrence of Hepatocellular Carcinoma in Patients With Cirrhosis: A Prospective Multicenter Trial (SEPT9_SuRV)
- Plain-language title
- Blood Test mSEPT9 to Predict Liver Cancer in Cirrhosis PatientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 10 June 2026