Circulating Cell-free DNA-based Epigenetic Biomarker mSEPT9 for Hepatocellular Carcinoma Detection in Cirrhosis (SEPT9-CROSS)
Hepatocellular Carcinoma, Cirrhosis
About this trial
This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, Cirrhosis, Circulating epigenetic biomarker, Plasma biomarker, SEPT9, Septin9, DNA methylation biomarker, Circulating DNA methylation biomarker, Alpha-fetoprotein
Eligibility Criteria
INCLUSION CRITERIA
- Patient aged 18 and over.
- Patient with a diagnosis of cirrhosis (alcohol, HBV, HBC, NASH, hemochromatosis, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis) with or without hepatocellular carcinoma (for each arm).
- Affiliation to the French Social Security System (Health Insurance)
NON-INCLUSION CRITERIA FOR CASES :
- Malignant liver tumor other than HCC: cholangiocarcinoma, hepatic metastasis of a carcinoma (e.g., colorectal adenocarcinoma);
- History of HCC treated by surgical resection, focal destruction [radiofrequency, stereotactic radiotherapy (CYBERKNIFE®)], arterial chemoembolization, or radioembolization within the last five years.
NON-INCLUSION CRITERIA FOR CASES AND CONTROLS:
- Legal protection measures;
- Pregnant woman;
- Hemodialysis, ongoing (possibility of interference with the test);
- Presence of associated cancer (e.g., colorectal adenocarcinoma, urothelial carcinoma, breast carcinoma, etc.) since less than five years;
- Presence of a hematological malignancy (no time limit).
Sites / Locations
- University Hospital of Nancy (CHRU de Nancy)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
HCC-free cirrhotic patients (Controls)
HCC-positive cirrhotic patients (Cases)
Cirrhotic patients enrolled in an HCC screening program by abdominal ultrasound and AFP every six months and followed at the Department of Hepatology of the University Hospital of Nancy. Each patient included will undergo a diagnostic test called "Epi proColon 2.0 CE" from Epigenomics, Inc (Berlin, Germany) also known as Plasma mSEPT9 test.
Cirrhotic patients followed at the Department of Hepatology of the University Hospital of Nancy who presents an HCC according to the AASLD guidelines. Each patient included will undergo a diagnostic test called "Epi proColon 2.0 CE" from Epigenomics, Inc (Berlin, Germany) also known as Plasma mSEPT9 test.