NCT06778317 mSEPT9 Biomarker for Predicting Hepatocellular Carcinoma Occurrence in Patients With Cirrhosis
| NCT ID | NCT06778317 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Central Hospital, Nancy, France |
| Condition | Hepatocellular Carcinoma (HCC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-06-03 |
| Primary Completion | 2033-06-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2025-06-03 with a primary completion date of 2033-06-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Mr. Franck Schreiner
STUDY DIRECTOR
Regional and University Hospital Center of Nancy
Frequently Asked Questions
Who can join the NCT06778317 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06778317 currently recruiting?
Yes, NCT06778317 is actively recruiting participants. Contact the research team at abderrahim.oussalah@univ-lorraine.fr for enrollment information.
Where is the NCT06778317 trial being conducted?
This trial is being conducted at Vandœuvre-lès-Nancy, France.
Who is sponsoring the NCT06778317 clinical trial?
NCT06778317 is sponsored by Central Hospital, Nancy, France. The principal investigator is Mr. Franck Schreiner at Regional and University Hospital Center of Nancy. The trial plans to enroll 400 participants.
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