Long Term Prediction of MASH-related HCC Risk by Proteomics

NCT07332611 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Bordeaux

Phase

Observational

Started

2026-01

Last updated

2026-01-12

Condition(s) studied

MASH-related HCC

Investigational drug(s) / intervention(s)

Proteomics

Proteomics: Proteomics

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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)

Primary outcome measure(s)

prognostic performance — year 15
prognostic performance of tissue proteomic profiling for predicting the 15-year risk of MASH-related HCC development from FFPE liver biopsies obtained at the time of MASH diagnosis usig sensitiy / specificity

Trial sites (1)

Facility	City	Region	Status
CHU Bordeaux	Pessac	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07332611 on ClinicalTrials.gov ↗ ← All trials in France