Status:
COMPLETED
Circulating Cell-free DNA-based Epigenetic Biomarker MSEPT9 for Hepatocellular Carcinoma Detection in Cirrhosis
Lead Sponsor:
Central Hospital, Nancy, France
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Groupement Interrégional de Recherche Clinique et d'Innovation
Conditions:
Hepatocellular Carcinoma
Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective evaluation of the circulating cell-free DNA-based epigenetic biomarker (mSEPT9) through a cross-sectional biomarker phase II design. The aim of the SEPT9-CROSS study is to assess the diagn...
Detailed 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 n...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2024
Estimated Enrollment :
529 Patients enrolled
Trial Details
Trial ID
NCT03311152
Start Date
February 12 2018
End Date
October 17 2024
Last Update
January 14 2025
Active Locations (1)
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1
University Hospital of Nancy (CHRU de Nancy)
Vandœuvre-lès-Nancy, France, 54511