mSEPT9 Biomarker for Predicting Hepatocellular Carcinoma Occurrence in Patients With Cirrhosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The study population consists of 400 adult patients with confirmed cirrhosis who are actively followed in specialized hepatology centers across multiple institutions. Participants must not have hepatocellular carcinoma (HCC) at the time of enrollment and must meet specific inclusion criteria, including established cirrhosis etiology and eligibility for routine clinical follow-up. Patients with conditions that may interfere with the study objectives, such as a history of malignancy or ongoing hemodialysis, are excluded. This cohort represents a diverse range of cirrhosis etiologies, including viral hepatitis, alcohol-related liver disease, and nonalcoholic steatohepatitis (NASH), to ensure the generalizability of findings.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Circulating mSEPT9 Biomarker Testing
Diagnostic testThis 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.
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: Patients With Cirrhosis Without Hepatocellular Carcinoma at Baseline1 intervention
Trial outcomes
Primary outcomes
1
Association Between mSEPT9 Test Switch and Hepatocellular Carcinoma (HCC) Development
Evaluate the relationship between a 'switch' in the mSEPT9 test result-defined as a transition from triple-negative (no methylation detected across all triplicates) to at least one positive triplicate-and the occurrence of hepatocellular carcinoma (HCC), as diagnosed using international criteria established by the AASLD.
Time frame
Annually for up to 60 months or until the occurrence of HCC, whichever occurs first.Secondary outcomes
1
Association Between mSEPT9 Test Switch and HCC Development by Cirrhosis Etiology
Assess the association between a 'switch' in mSEPT9 test results and the development of hepatocellular carcinoma (HCC), as diagnosed using international criteria (AASLD), across subgroups categorized by cirrhosis etiology, including alcohol use, hepatitis B (HBV), hepatitis C (HCV), and nonalcoholic steatohepatitis (NASH). A 'switch' in the mSEPT9 test result is defined as a transition from triple-negative (no methylation detected across all triplicates) to at least one positive triplicate.
Time frame
Annually for up to 60 months or until the occurrence of HCC, whichever occurs first.2
Association Between mSEPT9 Test Results and HCC-Related Mortality
HCC-specific mortality, defined as death attributable to hepatocellular carcinoma based on international classification of diseases (ICD) coding and/or clinical determination, stratified by positive or negative mSEPT9 test results (performed in triplicate).
Time frame
Annually for up to 60 months or until HCC-specific death occurs.3
Establishment of a Biobank for Genomic and Epigenomic Analysis
Number of Plasma and DNA Samples Collected and Stored for Genomic and Epigenomic Analysis, Including Data on Sample Quality, Quantity.
Time frame
For each participant, samples will be collected at enrollment (baseline) and during follow-up visits every 6 months for up to 60 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Central Hospital, Nancy, France
Lead sponsor
New Day Diagnostics
Collaborator
Source ClinicalTrials.gov