Clinical Research Directory
Browse clinical research sites, groups, and studies.
MSEPT9 Biomarker for Predicting Hepatocellular Carcinoma Occurrence in Patients with Cirrhosis
Sponsor: Central Hospital, Nancy, France
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
400
Start Date
2025-03-03
Completion Date
2031-03-03
Last Updated
2025-01-20
Healthy Volunteers
No
Interventions
Circulating mSEPT9 Biomarker Testing
This intervention involves the analysis of the circulating epigenetic biomarker mSEPT9 through plasma samples collected from patients with cirrhosis. The mSEPT9 test evaluates the methylation status of the SEPT9 gene promoter using a triplicate assay. A "switch" in the test status, defined as a transition from triple-negative (no methylation detected in any triplicate) to at least one positive triplicate, is being investigated as a prognostic marker for the development of hepatocellular carcinoma (HCC). The mSEPT9 test is conducted on plasma samples collected during routine blood draws at each of the 11 scheduled study visits. Samples are processed and analyzed in batches using specialized high-throughput equipment provided by Epigenomics/New Day Diagnostics. Results of the mSEPT9 test are not shared with clinicians during the study period to avoid influencing patient management, ensuring the test is purely investigational in this context.
Locations (1)
Regional and University Hospital Center of Nancy
Vandœuvre-lès-Nancy, France