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

NCT06493253 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1578

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

Sponsors & Collaborators

  • Nonalcoholic Steatohepatitis Clinical Research Network (NASH)

    collaborator UNKNOWN

  • Virginia Commonwealth University

    collaborator OTHER

  • PharmaNest, Inc

    lead INDUSTRY

Principal Investigators

  • Arun J Sanyal, MD · Virginia Commonwealth University

  • Cynthia Belhling, MD · University California San Diego

  • David E Kleiner, MD. PhD · Nonalcoholic Steatohepatitis Clinical Research Network

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

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 NCT06493253 on ClinicalTrials.gov