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Protein fingerprint may forecast liver cancer 15 years early

NCT ID NCT07332611

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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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 Results may not be published yet.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.
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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

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at stored liver biopsy samples from 30 people with MASH (a fatty liver disease) to see if a protein test can predict who will develop liver cancer within 15 years. Half of the participants later got liver cancer, and half did not. Researchers will compare the proteins in their biopsies to find a pattern that signals future cancer risk. If successful, this could lead to earlier detection and better monitoring for high-risk patients.

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Study facts

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

Participants

About 30 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Aug 2026

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

Patients who underwent a liver biopsy confirming the diagnosis of MASH

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.

Common inclusion criteria for all patients: * Age \>18 years * Patients who underwent a liver biopsy confirming the diagnosis of MASH, defined by standard histological criteria: presence of macrovesicular steatosis in \>5% of hepatocytes (graded 1, 2, or 3 according to the NAS score), lobular inflammation (graded 1, 2, or 3), and hepatocellular ballooning (graded 1 or 2), with a total NAS score \>5, as defined by Kleiner et al. * No documented opposition (during life, for deceased patients) to the reuse of their data and biological samples. Specific follow-up criteria for Group 1 (patients who developed HCC during MASH follow-up): * HCC diagnosed by imaging (CT or MRI according to LI-RADS diagnostic criteria from the American College of Radiology) or by histopathology (biopsy or surgical resection) between 1 and 15 years after the liver biopsy. * At least one imaging exam (ultrasound, CT, or MRI) confirming the absence of any suspicious nodule at least 1 year after the liver biopsy and prior to the diagnosis of HCC. Specific follow-up criteria for Group 2 (control patients who did not develop HCC during MASH follow-up): * Follow-up duration of more than 5 years after the liver biopsy. * At least one imaging exam (ultrasound, CT, or MRI) confirming the absence of any suspicious nodule at the date of last follow-up. Exclusion criteria: * Excessive alcohol consumption, as defined by international guidelines: more than 20 g of alcohol per day for women and more than 30 g per day for men, based on patient interview data or an AUDIT score \>8. * Other causes of chronic liver disease (viral, autoimmune, genetic, or drug-induced hepatitis), identified through biological analyses (viral serologies, autoimmune hepatitis antibody titers, genetic testing), histological features (suggestive lesions), or clinical history (medication use, family history). * Patients under legal protection (e.g., legal guardianship or judicial protection)

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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

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  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.

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Contacts and locations

Locations

  • CHU Bordeaux

    Pessac, France

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