NCT03311152

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
529

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

February 12, 2018

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2024

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

6.7 years

First QC Date

October 5, 2017

Last Update Submit

January 12, 2025

Conditions

Hepatocellular CarcinomaCirrhosis

Keywords

Hepatocellular carcinomaCirrhosisCirculating epigenetic biomarkerPlasma biomarkerSEPT9Septin9DNA methylation biomarkerCirculating DNA methylation biomarkerAlpha-fetoprotein

Outcome Measures

Primary Outcomes (1)

  • Presence of hepatocellular carcinoma.

    The diagnosis of hepatocellular carcinoma will be based on the guidelines of the American Association for the Study of Liver Diseases (AASLD) (Hepatology. 2011;53:1020-2). The adjudicating physicians will be blinded to patient results associated with the mSEPT9 test.

    The diagnosis of HCC will be based on overall patient's evaluation including clinical, biological and imaging workup which will be carried out during the consultation and/or the three months preceding or following the inclusion consultation.

Secondary Outcomes (1)

  • Presence of early hepatocellular carcinoma. Early hepatocellular carcinoma will be defined as a tumor smaller than 30 mm according to Kudo M (Liver Cancer. 2013;2:69-72).

    The diagnosis will be based on an overall patient's evaluation including clinical, biological and imaging workup which will be carried out during the consultation and/or the three months preceding or following the inclusion consultation.

Study Arms (2)

HCC-free cirrhotic patients (Controls)

EXPERIMENTAL

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.

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

HCC-positive cirrhotic patients (Cases)

EXPERIMENTAL

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.

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

Interventions

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

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

Also known as: Plasma mSEPT9 test
HCC-free cirrhotic patients (Controls)HCC-positive cirrhotic patients (Cases)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Nancy (CHRU de Nancy)

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularFibrosis

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Abderrahim OUSSALAH, MD, PhD

    University Hospital of Nancy, INSERM UMR_S 1256, Faculty of Medicine of Nancy, University of Lorraine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
The index test (mSEPT9) will be reported at the final step of the research, at time of data analysis.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Cross-sectional
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
OUSSALAH Abderrahim, MD, PhD

Study Record Dates

First Submitted

October 5, 2017

First Posted

October 17, 2017

Study Start

February 12, 2018

Primary Completion

October 17, 2024

Study Completion

October 17, 2024

Last Updated

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Final report, publication in a peer review journal. Main data and supplemental data.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Final report after data completion.
Access Criteria
After the publication of study results.

Locations

FR(1)