Circulating Cell-free DNA-based Epigenetic Biomarker mSEPT9 for Hepatocellular Carcinoma Detection in Cirrhosis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cirrhosis
- Hepatocellular Carcinoma
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Cross-sectional biomarker Phase II designMasking: Triple (Participant, Care Provider, Investigator)Masking Description: The index test (mSEPT9) will be reported at the final step of the research, at time of data analysis.Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Epigenetic alterations are a common hallmark of human cancer. Single epigenetic markers are starting to be incorporated into clinical practice; however, the translational use of these biomarkers has not been validated at the 'omics' level. This is strikingly the case in hepatocellular carcinoma (HCC...
Epigenetic alterations are a common hallmark of human cancer. Single epigenetic markers are starting to be incorporated into clinical practice; however, the translational use of these biomarkers has not been validated at the 'omics' level. This is strikingly the case in hepatocellular carcinoma (HCC) which represent the most common primary malignant tumor of the liver. Alpha-fetoprotein (AFP) has been widely used as a diagnostic marker of HCC; however, according to international guidelines (AASLD, EASL), AFP is unsuf?ciently sensitive or unsuf?ciently speci?c for use in a screening assay. Aberrantly methylated DNA sequences frequently occur in tumors and are detected in the circulation of cancer patients by polymerase chain reaction (PCR). SEPT9 is a significant epi-driver gene in liver carcinogenesis. The SEPT9 gene is a key regulator of cell division and tumor suppressor whose hypermethylation is associated with carcinogenesis. SEPT9 is involved in the onset of rat hepatocarcinogenesis and SEPT9-promoter hypermethylation was reported in HCC in man. SEPT9 expression is turned on in cells throughout the body and absent or diminished by aberrant promoter methylation in several types of cancer. Through an initial proof-of-concept pilot study from France and an independent replication study from Germany, we showed that the circulating cell-free DNA methylation-based epigenetic biomarker mSEPT9 is a promising plasma biomarker for diagnosing HCC in cirrhotic patients. The aim of the SEPT9-CROSS study is to confirm the diagnostic accuracy of the biomarker in a large-scale study of 440 cirrhotic patients recruited in the Nancy University Hospital.
Tracking Information
- NCT #
- NCT03311152
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Epigenomics, Inc
- Investigators
- Principal Investigator: Abderrahim OUSSALAH, MD, PhD University Hospital of Nancy, INSERM U954, Faculty of Medicine of Nancy, University of Lorraine
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