Not Yet RecruitingNot Applicable

Long Term Prediction of MASH-related HCC Risk by Proteomics

France30 participantsStarted 2026-01

Plain-language summary

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), affects over 25% of the global population and is increasingly associated with obesity and type 2 diabetes. Metabolic Dysfunction-Associated Steatohepatitis (MASH), a progressive form of MASLD, can lead to cirrhosis and hepatocellular carcinoma (HCC). MASH is now responsible for up to 35% of HCC cases worldwide, including in non-cirrhotic patients who fall outside routine HCC screening recommendations. Unfortunately, no predictive biomarkers of malignant transformation are currently available in clinical practice. The study hypothesizes that tissue proteomic profiling of liver biopsies using mass spectrometry can predict HCC risk in MASH patients. A retrospective study will analyze liver biopsies performed at the time of MASH diagnosis, along with clinical data from 30 patients at Bordeaux University Hospital: 15 patients with MASH who subsequently developed HCC within 15 years (group 1), and 15 control patients with MASH who did not develop HCC (group 2). Proteomic data will be compared to clinical outcomes to identify a predictive proteomic signature. Control subjects will be selected to closely match group 1 patients in terms of established HCC risk factors (age, sex, diabetes, fibrosis stage), thereby reducing potential confounding. ProteoMASH is the first study aiming to define a predictive proteomic signature for HCC in MASH. If successful, findings will be validated in national and international cohorts to improve early detection and personalized follow-up in MASH patients

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 p…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

prognostic performance

Timeframe: year 15

Trial details

NCT IDNCT07332611

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08

Contact for this trial

Faiza Chermak, MD

+335 57 62 34 47 faiza.chermak@chu-bordeaux.fr

View on ClinicalTrials.gov More MASH-related HCC trials