NCT06778317Recruiting
mSEPT9 Biomarker for Predicting Hepatocellular Carcinoma Occurrence in Patients With Cirrhosis
Evaluation of the Circulating Epigenetic Biomarker mSEPT9 for Predicting the Occurrence of Hepatocellular Carcinoma in Patients With Cirrhosis: A Prospective Multicenter Trial (SEPT9_SuRV)
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 27 Dec 2024
- Start date
- 3 Jun 2025
- Primary completion date
- 3 Jun 2033
- Lead sponsor
- Central Hospital, Nancy, France
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06778317
What you commit to
- Study type: Observational
- Planned participants: 400
- From 3 Jun 2025 to the primary completion date, 3 Jun 2033
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with psychiatric conditions receiving care under legal constraints (e.g., articles L.3212-1 and L.3213-1).
Other illness
- 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).
Age
- Minors or individuals younger than 18 years.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Regional and University Hospital Center of Nancy Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.