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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

529 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-12

Study Completion Date

2024-10-17

Brief Summary

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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.

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Detailed Description

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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 unsufﬁciently sensitive or unsufﬁciently speciﬁc 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 630 cirrhotic patients recruited in the participating centers.

Conditions

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Hepatocellular Carcinoma Cirrhosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Cross-sectional

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

The index test (mSEPT9) will be reported at the final step of the research, at time of data analysis.

Study Groups

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HCC-free cirrhotic patients (Controls)

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.

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

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

HCC-positive cirrhotic patients (Cases)

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.

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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"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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Plasma mSEPT9 test

Eligibility Criteria

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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)

* 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No