NCT06493253

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,578 (actual)
• Sponsor: PharmaNest, Inc · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: —

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).

Detailed description

MASH (Metabolic Dysfunction-Associated Steatohepatitis): MASH presents histological liver changes similar to those caused by alcohol abuse, but occurs in the absence of alcohol intake. It is common among adults with conditions such as obesity and type-2 diabetes. Severe MASH is expected to become a leading cause of end-stage liver disease. Current Challenges: There are currently no fully approved treatments for MASH which places a significant burden on liver health and transplantation. Diagnosis and assessment rely on subjective histological reviews, which are prone to variability and limitations in detecting subtle changes. Therefore, there is an urgent need for accurate and continuous histological biomarkers. FibroNest Ph-FCS Solution: The FibroNest Ph-FCS offers a promising solution by utilizing high-resolution digital pathology and sophisticated algorithmic methods for sensitive and reproducible fibrosis severity assessment and prediction of clinical events. In a 2003 proof-of-concept retrospective study on 400 patients, the Ph-FCS demonstrated excellent prognostic performance. Proposed Study: This multi-center retrospective study aims to confirm the Ph-FCS's prognostic value using patient liver biopsies and clinical outcome data from the NAFLD Adult Database 2 registry (NCT01030484). The prognostic performance of the Ph-FCS will be compared to: 1. The NASH-CRN Histological Fibrosis Stages established from the same biopsies. 2. Non-invasive biomarkers like Fib-4 and elastography/Fibroscan, also collected retrospectively from the point of initial diagnosis. Study Objectives: (i) Confirm the Ph-FCS's prognostic utility on a large scale. (ii) Compare the Ph-FCS's prognostic performance with that of the NASH-CRN Fibrosis Stages established from the same biopsies. (iii) Compare biopsy-based Ph-FCS with non-invasive biomarkers.

Conditions

• Metabolic Dysfunction-associated Steatotic Liver Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-03-15
• Completion: 2026-03-15
• First posted: 2024-07-09
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States