Long Term Prediction of MASH-related HCC Risk by Proteomics

NCT07332611 | Not Yet Recruiting

• 1 other identifier: CHUBX 2025/026
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Carcinoma; Hepatocellular; Steatohepatitis; Nonalcoholic; Proteomics

Outcome Measures

Primary Outcomes (1)

• prognostic performance

  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

  year 15

Study Arms (2)

diagnostic liver biopsy confirming MASH prior to the development of HCC

Patients, mostly deceased, who had a diagnostic liver biopsy confirming MASH prior to the development of HCC, with a time interval between the biopsy and HCC diagnosis ranging from 1 to 15 years

Other: Proteomics

diagnostic liver biopsy confirming MASH who did not develop HCC

Control patients with a diagnostic liver biopsy confirming MASH who did not develop HCC during follow-up.

Other: Proteomics

Interventions

Proteomics OTHER

Proteomics

diagnostic liver biopsy confirming MASH prior to the development of HCC; diagnostic liver biopsy confirming MASH who did not develop HCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent a liver biopsy confirming the diagnosis of MASH

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux

Pessac, France

Location

MeSH Terms

Conditions

Carcinoma; Fatty Liver

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Diseases; Digestive System Diseases

Central Study Contacts

Faiza Chermak, MD

CONTACT

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

Adele Delamarre, MD

CONTACT

+335 57 62 34 47; adèle.delamarre@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)