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Circulating Cell-free DNA-based Epigenetic Biomarker MSEPT9 for Hepatocellular Carcinoma Detection in Cirrhosis

NCT03311152 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 529

Last updated 2025-01-14

No results posted yet for this study

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 diagnostic accuracy of the plasma mSEPT9 biomarker in a large-scale study of 639 cirrhotic patients recruited in the participating centers.

Conditions

Interventions

DIAGNOSTIC_TEST

"Epi proColon 2.0 CE" test from Epigenomics, Inc (Berlin, Germany)

The mSEPT9 assay consists of DNA extraction from plasma, bisulfite conversion of DNA, purification of bis-DNA, and real-time PCR.

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Groupement Interrégional de Recherche Clinique et d'Innovation

    collaborator OTHER

  • Epigenomics, Inc

    collaborator INDUSTRY

  • New Day Diagnostics

    collaborator NETWORK

  • Central Hospital, Nancy, France

    lead OTHER

Principal Investigators

  • Abderrahim OUSSALAH, MD, PhD · University Hospital of Nancy, INSERM UMR_S 1256, Faculty of Medicine of Nancy, University of Lorraine

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-12
Primary Completion
2024-10-17
Completion
2024-10-17

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03311152 on ClinicalTrials.gov