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Digital Pathology and AI for Liver Outcomes in MASLD
Sponsor: PharmaNest, Inc
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).
Official title: Epidemiologic Liver Outcomes Retrospective Study to Confirm The Prognostic Value of the FibroNest Digital Pathology Fibrosis Biomarker (Ph-FCS) in Patients With MASLD (DPAILO-1)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1241
Start Date
2025-09-01
Completion Date
2026-08-15
Last Updated
2026-08-24
Healthy Volunteers
No
Interventions
Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS)
Biomarker name: FibroNest Phenotypic Fibrosis Composite Score Acronym: FibroNest Ph-FCS Type of Biomarker: Histologic based, Digital, Quantitative Image Analysis, Imaging modality Definition: A quantitative, normalized (no unit) and continuous composite score that aggregates quantitative histological features of fibrosis severity measured by high resolution quantitative image analysis.
Locations (3)
The Chinese University of Hong Kong
Shatin, Hong Kong
Fundació de Recerca Clinic Barcelona
Barcelona, Spain
University of Seville
Seville, Spain