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Long Term Prediction of MASH-related HCC Risk by Proteomics

NCT07332611 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-01-12

No results posted yet for this 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

Conditions

  • MASH-related HCC

Interventions

OTHER

Proteomics

Proteomics

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07332611 on ClinicalTrials.gov