mSEPT9 Biomarker for Predicting Hepatocellular Carcinoma Occurrence in Patients With Cirrhosis

Sponsor
Central Hospital, Nancy, France
Study ID
NCT06778317
Status
Recruiting
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Conditions

  • Cirrhosis
  • Epigenomics
  • Hepatocellular Carcinoma (HCC)
  • Risk Prediction for Liver Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Circulating mSEPT9 Biomarker Testing — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

First listed
Jan 16, 2025
Start date
Jun 3, 2025
Status verified
Jun 2026
Primary completion
Jun 3, 2033
Completion
Jun 3, 2033

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Association Between mSEPT9 Test Switch and Hepatocellular Carcinoma (HCC) Development [ Time Frame: Annually for up to 60 months or until the occurrence of HCC, whichever occurs first. ]

Central Contacts

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