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Blood test may spot liver cancer risk years early in cirrhosis patients

NCT ID NCT06778317

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a blood test that looks for a marker called mSEPT9 can predict liver cancer in people with cirrhosis. Researchers will follow 400 patients for up to 5 years, taking blood samples every 6 months to see if changes in this marker signal cancer risk. The goal is to catch liver cancer earlier and tailor screening to those who need it most.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mSEPT9 blood test
What this could lead to
If successful, this blood test could help doctors identify cirrhosis patients at highest risk for liver cancer, allowing for earlier detection and personalized monitoring.
What could go wrong
This is an observational study, not a treatment trial. The test may not accurately predict cancer in all patients, and results may not change outcomes. Further studies would be needed to confirm its usefulness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of 400 adult patients with confirmed cirrhosis who are actively followed in specialized hepatology centers across multiple institutions. Participants must not have hepatocellular carcinoma (HCC) at the time of enrollment and must meet specific inclusion criteria, including established cirrhosis etiology and eligibility for routine clinical follow-up. Patients with conditions that may interfere with the study objectives, such as a history of malignancy or ongoing hemodialysis, are excluded. This cohort represents a diverse range of cirrhosis etiologies, including viral hepatitis, alcohol-related liver disease, and nonalcoholic steatohepatitis (NASH), to ensure the generalizability of findings.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged 18 years or older. * Patients diagnosed with cirrhosis confirmed by clinical, biochemical, radiological, or histological criteria. * Cirrhosis attributable to one or more of the following etiologies: alcohol, hepatitis C (HCV), hepatitis B (HBV), nonalcoholic steatohepatitis (NASH), hemochromatosis, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, or cryptogenic causes. * Patients actively followed in one of the participating study centers. * Patients affiliated with a social security program or equivalent. * Patients with a body weight greater than 45 kg. * Patients who have been fully informed about the study procedures and have provided oral informed consent. Exclusion Criteria: * History of hepatocellular carcinoma (HCC). * History of any other primary or secondary malignant liver tumor. * Diagnosis of malignancy or hematologic disorders within the past 5 years (without time limitation for hematologic malignancies). * Patients currently undergoing hemodialysis. * Pregnant or breastfeeding women. * Individuals under legal protection (e.g., guardianship, curatorship) or unable to provide consent. * Minors or individuals younger than 18 years. * Individuals deprived of liberty by judicial or administrative order. * Patients with psychiatric conditions receiving care under legal constraints (e.g., articles L.3212-1 and L.3213-1). * Patients unable to comply with the study protocol requirements.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Regional and University Hospital Center of Nancy

    RECRUITING

    Vandœuvre-lès-Nancy, 54511, France

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