Hepatocellular Carcinoma (HCC)SEPT9_SuRVNCT06778317
mSEPT9 Biomarker for Predicting Hepatocellular Carcinoma Occurrence in Patients With Cirrhosis
An observational study of Hepatocellular Carcinoma (HCC) and Cirrhosis, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Cirrhosis, Risk Prediction for Liver Cancer
- What is being tested?
- Circulating mSEPT9 Biomarker Testing
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2025to 3 Jun 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Regional and University Hospital Center of Nancy
Vandœuvre-lès-Nancy, 54511
Prof. Abderrahim OUSSALAH, MD, PhD, +33383153629, abderrahim.oussalah@univ-lorraine.fr
About this study
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)
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.
Read the detailed description
This study is a prospective, multicenter cohort trial designed to assess the prognostic utility of the circulating epigenetic biomarker mSEPT9 in predicting the development of hepatocellular carcinoma (HCC) among patients with cirrhosis. The trial involves 400 participants who are confirmed to have cirrhosis and no evidence of HCC at baseline.
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.
- Being tested
- Circulating mSEPT9 Biomarker Testing
- Keywords
- Hepatocellular Carcinoma, Cirrhosis, mSEPT9 Biomarker, Epigenetics, Risk Prediction, Liver Cancer Surveillance, Prospective Cohort Study, Non-Invasive Biomarkers, Personalized Medicine, Epigenomics, Risk Stratification
- Medical subject headings
- Carcinoma, Hepatocellular, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating mSEPT9 Biomarker TestingDiagnostic test
Also called Plasma mSEPT9 Testing, Epigenetic Biomarker Analysis, mSEPT9 Methylation 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Circulating mSEPT9 Biomarker Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Annually for up to 60 months or until the occurrence of HCC, whichever occurs first.
Secondary outcomes (3)
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.
Measured: Annually for up to 60 months or until the occurrence of HCC, whichever occurs first.
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).
Measured: Annually for up to 60 months or until HCC-specific death occurs.
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.
Measured: For each participant, samples will be collected at enrollment (baseline) and during follow-up visits every 6 months for up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start3 Jun 2025
- Primary completion3 Jun 2033 (estimated)
- Study completion3 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- New Day Diagnostics
- Responsible party
- Sponsor
- Investigators
- Mr. Franck Schreiner, Study director, Regional and University Hospital Center of Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778317
- Sponsor's protocol ID
- 2022-A01664-39
- Acronym
- SEPT9_SuRV
- Status last verified
- Jun 2026
- First submitted
- 27 Dec 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The study will share individual participant data (IPD) related to anonymized clinical, biological, and imaging results, as well as the results of mSEPT9 biomarker analyses. This includes: * Demographic data * Clinical characteristics, including cirrhosis etiology and disease severity (e.g., Child-Pugh score) * Results from routine imaging and biological assessments * mSEPT9 test results (e.g., triple-negative, positive status) * Outcome measures, such as the occurrence of hepatocellular carcinoma (HCC) and mortality All shared data will be pseudo-anonymized to ensure participant confidentiality and will be accessible to researchers upon reasonable request, in accordance with regulatory and ethical guidelines.
Publications
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.
PubMed 29627389Nahon P, Layese R, Bourcier V, Cagnot C, Marcellin P, Guyader D, Pol S, Larrey D, De Ledinghen V, Ouzan D, Zoulim F, Roulot D, Tran A, Bronowicki JP, Zarski JP, Riachi G, Cales P, Peron JM, Alric L, Bourliere M, Mathurin P, Blanc JF, Abergel A, Serfaty L, Mallat A, Grange JD, Attali P, Bacq Y, Wartelle C, Dao T, Thabut D, Pilette C, Silvain C, Christidis C, Nguyen-Khac E, Bernard-Chabert B, Zucman D, Di Martino V, Sutton A, Roudot-Thoraval F, Audureau E; ANRS CO12 CirVir Group. Incidence of Hepatocellular Carcinoma After Direct Antiviral Therapy for HCV in Patients With Cirrhosis Included in Surveillance Programs. Gastroenterology. 2018 Nov;155(5):1436-1450.e6. doi: 10.1053/j.gastro.2018.07.015. Epub 2018 Jul 19.
PubMed 30031138Moon AM, Weiss NS, Beste LA, Su F, Ho SB, Jin GY, Lowy E, Berry K, Ioannou GN. No Association Between Screening for Hepatocellular Carcinoma and Reduced Cancer-Related Mortality in Patients With Cirrhosis. Gastroenterology. 2018 Oct;155(4):1128-1139.e6. doi: 10.1053/j.gastro.2018.06.079. Epub 2018 Jul 5.
PubMed 29981779Heimbach JK, Kulik LM, Finn RS, Sirlin CB, Abecassis MM, Roberts LR, Zhu AX, Murad MH, Marrero JA. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018 Jan;67(1):358-380. doi: 10.1002/hep.29086. No abstract available.
PubMed 28130846Forner A, Reig M, Bruix J. Hepatocellular carcinoma. Lancet. 2018 Mar 31;391(10127):1301-1314. doi: 10.1016/S0140-6736(18)30010-2. Epub 2018 Jan 5.
PubMed 29307467European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):182-236. doi: 10.1016/j.jhep.2018.03.019. Epub 2018 Apr 5. No abstract available.
PubMed 29628281Sharma SA, Kowgier M, Hansen BE, Brouwer WP, Maan R, Wong D, Shah H, Khalili K, Yim C, Heathcote EJ, Janssen HLA, Sherman M, Hirschfield GM, Feld JJ. Toronto HCC risk index: A validated scoring system to predict 10-year risk of HCC in patients with cirrhosis. J Hepatol. 2017 Aug 24:S0168-8278(17)32248-1. doi: 10.1016/j.jhep.2017.07.033. Online ahead of print.
PubMed 28844936Moran S, Martinez-Cardus A, Boussios S, Esteller M. Precision medicine based on epigenomics: the paradigm of carcinoma of unknown primary. Nat Rev Clin Oncol. 2017 Nov;14(11):682-694. doi: 10.1038/nrclinonc.2017.97. Epub 2017 Jul 4.
PubMed 28675165Hao X, Luo H, Krawczyk M, Wei W, Wang W, Wang J, Flagg K, Hou J, Zhang H, Yi S, Jafari M, Lin D, Chung C, Caughey BA, Li G, Dhar D, Shi W, Zheng L, Hou R, Zhu J, Zhao L, Fu X, Zhang E, Zhang C, Zhu JK, Karin M, Xu RH, Zhang K. DNA methylation markers for diagnosis and prognosis of common cancers. Proc Natl Acad Sci U S A. 2017 Jul 11;114(28):7414-7419. doi: 10.1073/pnas.1703577114. Epub 2017 Jun 26.
PubMed 28652331Ngwa JS, Cabral HJ, Cheng DM, Pencina MJ, Gagnon DR, LaValley MP, Cupples LA. A comparison of time dependent Cox regression, pooled logistic regression and cross sectional pooling with simulations and an application to the Framingham Heart Study. BMC Med Res Methodol. 2016 Nov 3;16(1):148. doi: 10.1186/s12874-016-0248-6.
PubMed 27809784Bruix J, Reig M, Sherman M. Evidence-Based Diagnosis, Staging, and Treatment of Patients With Hepatocellular Carcinoma. Gastroenterology. 2016 Apr;150(4):835-53. doi: 10.1053/j.gastro.2015.12.041. Epub 2016 Jan 12.
PubMed 26795574Villanueva A, Portela A, Sayols S, Battiston C, Hoshida Y, Mendez-Gonzalez J, Imbeaud S, Letouze E, Hernandez-Gea V, Cornella H, Pinyol R, Sole M, Fuster J, Zucman-Rossi J, Mazzaferro V, Esteller M, Llovet JM; HEPTROMIC Consortium. DNA methylation-based prognosis and epidrivers in hepatocellular carcinoma. Hepatology. 2015 Jun;61(6):1945-56. doi: 10.1002/hep.27732. Epub 2015 Mar 18.
PubMed 25645722Chaiteerakij R, Addissie BD, Roberts LR. Update on biomarkers of hepatocellular carcinoma. Clin Gastroenterol Hepatol. 2015 Feb;13(2):237-45. doi: 10.1016/j.cgh.2013.10.038. Epub 2013 Nov 23.
PubMed 24275343Mair RD, Valenzuela A, Ha NB, Ayoub WS, Daugherty T, Lutchman GA, Garcia G, Ahmed A, Nguyen MH. Incidence of hepatocellular carcinoma among US patients with cirrhosis of viral or nonviral etiologies. Clin Gastroenterol Hepatol. 2012 Dec;10(12):1412-7. doi: 10.1016/j.cgh.2012.08.011. Epub 2012 Aug 16.
PubMed 22902757Kakehashi A, Ishii N, Shibata T, Wei M, Okazaki E, Tachibana T, Fukushima S, Wanibuchi H. Mitochondrial prohibitins and septin 9 are implicated in the onset of rat hepatocarcinogenesis. Toxicol Sci. 2011 Jan;119(1):61-72. doi: 10.1093/toxsci/kfq307. Epub 2010 Oct 8.
PubMed 20935162
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06778317
- Acronym / sponsor ID
- SEPT9_SuRV / 2022-A01664-39
- Keywords
- Hepatocellular Carcinoma, Cirrhosis, mSEPT9 Biomarker, Epigenetics, Risk Prediction, Liver Cancer Surveillance, Prospective Cohort Study, Non-Invasive Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- New Day Diagnostics
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 3 Jun 2033 (estimated)
- Study completion
- 3 Jun 2033 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective, multicenter cohort trial designed to assess the prognostic utility of the circulating epigenetic biomarker mSEPT9 in predicting the development of hepatocellular carcinoma (HCC) among patients with cirrhosis. The trial involves 400 participants who are confirmed to have cirrhosis and no evidence of HCC at baseline.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Cirrhosis Without Hepatocellular Carcinoma at Baseline | – | Diagnostic Test: Circulating mSEPT9 Biomarker TestingThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulating mSEPT9 Biomarker TestingAlso: Plasma mSEPT9 Testing, Epigenetic Biomarker Analysis, mSEPT9 Methylation 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. | Diagnostic test | Patients With Cirrhosis Without Hepatocellular Carcinoma at Baseline |
Primary outcome
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.
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.
3 secondary outcomes
Association Between mSEPT9 Test Switch and HCC Development by Cirrhosis Etiology
Time frame: Annually for up to 60 months or until the occurrence of HCC, whichever occurs first.
Association Between mSEPT9 Test Results and HCC-Related Mortality
Time frame: Annually for up to 60 months or until HCC-specific death occurs.
Establishment of a Biobank for Genomic and Epigenomic Analysis
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 29627389Oussalah 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.
- Background: PubMed 30031138Nahon P, Layese R, Bourcier V, Cagnot C, Marcellin P, Guyader D, Pol S, Larrey D, De Ledinghen V, Ouzan D, Zoulim F, Roulot D, Tran A, Bronowicki JP, Zarski JP, Riachi G, Cales P, Peron JM, Alric L, Bourliere M, Mathurin P, Blanc JF, Abergel A, Serfaty L, Mallat A, Grange JD, Attali P, Bacq Y, Wartelle C, Dao T, Thabut D, Pilette C, Silvain C, Christidis C, Nguyen-Khac E, Bernard-Chabert B, Zucman D, Di Martino V, Sutton A, Roudot-Thoraval F, Audureau E; ANRS CO12 CirVir Group. Incidence of Hepatocellular Carcinoma After Direct Antiviral Therapy for HCV in Patients With Cirrhosis Included in Surveillance Programs. Gastroenterology. 2018 Nov;155(5):1436-1450.e6. doi: 10.1053/j.gastro.2018.07.015. Epub 2018 Jul 19.
- Background: PubMed 29981779Moon AM, Weiss NS, Beste LA, Su F, Ho SB, Jin GY, Lowy E, Berry K, Ioannou GN. No Association Between Screening for Hepatocellular Carcinoma and Reduced Cancer-Related Mortality in Patients With Cirrhosis. Gastroenterology. 2018 Oct;155(4):1128-1139.e6. doi: 10.1053/j.gastro.2018.06.079. Epub 2018 Jul 5.
- Background: PubMed 28130846Heimbach JK, Kulik LM, Finn RS, Sirlin CB, Abecassis MM, Roberts LR, Zhu AX, Murad MH, Marrero JA. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018 Jan;67(1):358-380. doi: 10.1002/hep.29086. No abstract available.
- Background: PubMed 29307467Forner A, Reig M, Bruix J. Hepatocellular carcinoma. Lancet. 2018 Mar 31;391(10127):1301-1314. doi: 10.1016/S0140-6736(18)30010-2. Epub 2018 Jan 5.
- Background: PubMed 29628281European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):182-236. doi: 10.1016/j.jhep.2018.03.019. Epub 2018 Apr 5. No abstract available.
- Background: PubMed 28844936Sharma SA, Kowgier M, Hansen BE, Brouwer WP, Maan R, Wong D, Shah H, Khalili K, Yim C, Heathcote EJ, Janssen HLA, Sherman M, Hirschfield GM, Feld JJ. Toronto HCC risk index: A validated scoring system to predict 10-year risk of HCC in patients with cirrhosis. J Hepatol. 2017 Aug 24:S0168-8278(17)32248-1. doi: 10.1016/j.jhep.2017.07.033. Online ahead of print.
- Background: PubMed 28675165Moran S, Martinez-Cardus A, Boussios S, Esteller M. Precision medicine based on epigenomics: the paradigm of carcinoma of unknown primary. Nat Rev Clin Oncol. 2017 Nov;14(11):682-694. doi: 10.1038/nrclinonc.2017.97. Epub 2017 Jul 4.
- Background: PubMed 28652331Hao X, Luo H, Krawczyk M, Wei W, Wang W, Wang J, Flagg K, Hou J, Zhang H, Yi S, Jafari M, Lin D, Chung C, Caughey BA, Li G, Dhar D, Shi W, Zheng L, Hou R, Zhu J, Zhao L, Fu X, Zhang E, Zhang C, Zhu JK, Karin M, Xu RH, Zhang K. DNA methylation markers for diagnosis and prognosis of common cancers. Proc Natl Acad Sci U S A. 2017 Jul 11;114(28):7414-7419. doi: 10.1073/pnas.1703577114. Epub 2017 Jun 26.
- Background: PubMed 27809784Ngwa JS, Cabral HJ, Cheng DM, Pencina MJ, Gagnon DR, LaValley MP, Cupples LA. A comparison of time dependent Cox regression, pooled logistic regression and cross sectional pooling with simulations and an application to the Framingham Heart Study. BMC Med Res Methodol. 2016 Nov 3;16(1):148. doi: 10.1186/s12874-016-0248-6.
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- Individual participant dataSharing planned: Yes. The study will share individual participant data (IPD) related to anonymized clinical, biological, and imaging results, as well as the results of mSEPT9 biomarker analyses. This includes: * Demographic data * Clinical characteristics, including cirrhosis etiology and disease severity (e.g., Child-Pugh score) * Results from routine imaging and biological assessments * mSEPT9 test results (e.g., triple-negative, positive status) * Outcome measures, such as the occurrence of hepatocellular carcinoma (HCC) and mortality All shared data will be pseudo-anonymized to ensure participant confidentiality and will be accessible to researchers upon reasonable request, in accordance with regulatory and ethical guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mr. Franck Schreiner study director
Regional and University Hospital Center of Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC) and Cirrhosis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Abderrahim OUSSALAH, MD, PhD (+33383153629, abderrahim.oussalah@univ-lorraine.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06778317, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.