CompletedNot Applicable

Digital Pathology and AI for Liver Outcomes in MASLD

Hong Kong, Spain1,241 participantsStarted 2025-09-01

Plain-language summary

The aim of this multi-center, retrospective epidemiologic study is to confirm the prognostic performance of the Digital Pathology (DP) FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS), derived from standard digital pathology liver biopsy images, in predicting clinical hepatic decompensation events in patients with metabolic dysfunction-associated steatohepatitis (MASH).

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

Inclusion Criteria: * Adult pts ( \>=18 years old) with MASLD defined histologically. * Liver biopsy with fibrosis stains available for digitization or already digitized. * Clinical follow-up \>1 year available recording liver-related outcomes either through hospitalization ICD-10 codes or through clinical observation Exclusion Criteria: * Liver diseases other than MASLD Note: no exclusion based on bariatric surgery, significant weight loss or enrollment in NASH clinical studies, but data is collected for data analysis / competing effects (see data analysis plan)

What they're measuring

Performance of Hepatic Decompensation Event predictive value of the FibroNest Ph-FCS

Timeframe: Time-to-event analysis between 2 and 10 years

Trial details

NCT IDNCT06344364

SponsorPharmaNest, Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-03-01

View on ClinicalTrials.gov More Metabolic Dysfunction-associated Steatotic Liver Disease trials