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NCT06493253

Digital Pathology and AI for Liver Outcomes in MASLD (DPAILO-2)

Sponsor: PharmaNest, Inc

View on ClinicalTrials.gov

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-2)

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

1519

Start Date

2025-09-01

Completion Date

2026-03-15

Last Updated

2026-08-21

Healthy Volunteers

Not specified

Interventions

DIAGNOSTIC_TEST

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

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States