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Digital Pathology and AI for Liver Outcomes in MASLD

NCT06344364 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1241

Last updated 2026-03-23

No results posted yet for this study

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).

Conditions

  • Metabolic Dysfunction-associated Steatotic Liver Disease

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 score that aggregates quantitative histological features of fibrosis severity measured by high resolution quantitative image analysis.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    collaborator OTHER

  • University of Seville

    collaborator OTHER

  • Fundacio Clinic Barcelona

    collaborator OTHER

  • Sorbonne University

    collaborator OTHER

  • PharmaNest, Inc

    lead INDUSTRY

Principal Investigators

  • Vlad Ratziu, MD, PhD · Sorbonne University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-03-01
Completion
2026-03-15

Countries

  • Hong Kong
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06344364 on ClinicalTrials.gov