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New blood test may spot liver cancer sooner in High-Risk patients

NCT ID NCT03311152

Diagnosis Sponsor: Central Hospital, Nancy, France Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 639 adults with cirrhosis to see if a blood test called mSEPT9 can detect liver cancer (hepatocellular carcinoma) better than the current standard test (AFP). Participants gave an extra blood sample during routine care, and researchers compared how well each test identified cancer. The goal is to find a more accurate, non-invasive way to catch liver cancer early in people with cirrhosis.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

639 people

The number who actually took part.

Started

Feb 2018

Finished

Oct 2024

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.

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 * 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).

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver Fibrosis hepatocellular carcinoma

As listed by the trial registrant

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

Cirrhosis Hepatocellular carcinoma

Contacts and locations

Locations

  • University Hospital of Nancy (CHRU de Nancy)

    Vandœuvre-lès-Nancy, 54511, France

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