MSEPT9 Biomarker for Predicting Hepatocellular Carcinoma Occurrence in Patients with Cirrhosis
NCT ID: NCT06778317
Last Updated: 2025-01-20
Study Results
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Basic Information
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NOT_YET_RECRUITING
400 participants
OBSERVATIONAL
2025-03-03
2031-03-03
Brief Summary
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Detailed Description
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The study's primary focus is to evaluate the association between a "switch" in the mSEPT9 test-from a triple-negative status (no methylation detected across triplicate assays) to at least one positive triplicate-and the subsequent occurrence of HCC. Secondary objectives include assessing this association across different etiologies of cirrhosis (e.g., viral hepatitis, alcohol-related liver disease, nonalcoholic steatohepatitis) and its correlation with HCC-related mortality.
Participants will undergo standardized clinical, biological, and imaging assessments every six months over a follow-up period of 60 months, as per international guidelines for cirrhosis management. In addition to routine care, blood samples will be collected at each visit for mSEPT9 testing. These samples will be processed, stored at -80°C, and analyzed in batches to assess mSEPT9 levels.
The findings from this study are expected to address the unmet need for reliable, non-invasive biomarkers for HCC risk prediction, potentially leading to personalized surveillance strategies and earlier intervention for patients with cirrhosis. Data will be managed using an electronic case report form (eCRF) to ensure secure, standardized documentation across all participating centers. Results from mSEPT9 testing will not influence clinical management during the study period but will be analyzed to determine their predictive value for HCC development and prognosis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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New Day Diagnostics
NETWORK
Central Hospital, Nancy, France
OTHER
Responsible Party
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Principal Investigators
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Mr. Franck Schreiner
Role: STUDY_DIRECTOR
Regional and University Hospital Center of Nancy
Locations
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Regional and University Hospital Center of Nancy
Vandœuvre-lès-Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Oussalah A, Rischer S, Bensenane M, Conroy G, Filhine-Tresarrieu P, Debard R, Forest-Tramoy D, Josse T, Reinicke D, Garcia M, Luc A, Baumann C, Ayav A, Laurent V, Hollenbach M, Ripoll C, Gueant-Rodriguez RM, Namour F, Zipprich A, Fleischhacker M, Bronowicki JP, Gueant JL. Plasma mSEPT9: A Novel Circulating Cell-free DNA-Based Epigenetic Biomarker to Diagnose Hepatocellular Carcinoma. EBioMedicine. 2018 Apr;30:138-147. doi: 10.1016/j.ebiom.2018.03.029. Epub 2018 Mar 28.
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Other Identifiers
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2022-A01664-39
Identifier Type: -
Identifier Source: org_study_id
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