protocolSection identificationModule nctId: NCT06344364, orgStudyIdInfo id: PHN 1-080-23, briefTitle: Digital Pathology and AI for Liver Outcomes in MASLD, acronym: DPAILO-1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: PharmaNest, Inc, class: INDUSTRY, collaborators name: Chinese University of Hong Kong, collaborators name: University of Edinburgh, collaborators name: University of Seville, collaborators name: Imperial College London, collaborators name: Icahn School of Medicine at Mount Sinai, collaborators name: Fundacio Clinic Barcelona, descriptionModule briefSummary: 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)., conditionsModule conditions: Metabolic Dysfunction-associated Steatotic Liver Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS), outcomesModule primaryOutcomes measure: Performance of Hepatic Decompensation Event predictive value of the FibroNest Ph-FCS, secondaryOutcomes measure: Performance of Hepatic Decompensation Event predictive value of the FIB-4 biomarker, a non-invasive test, secondaryOutcomes measure: Performance of Hepatic Decompensation Event predictive value of the elastography (Fibroscan) biomarker, a non-invasive test, secondaryOutcomes measure: Performance of Hepatic Decompensation Event predictive value of the FibroNest Parenchymal Tissue Adjusted Phenotypic Fibrosis Composite Score (Pt-Ph-FCS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Icahn School of Medicine at Mount Sinai, city: New York, state: New York, zip: 10029, country: United States, contacts name: Meena Bansal, MD, role: CONTACT, email: meena.bansal@mssm.edu, geoPoint lat: 40.71427, lon: -74.00597, locations facility: The Chinese University of Hong Kong, city: Sha Tin, country: Hong Kong, contacts name: Vincent Wong, PhD, role: CONTACT, email: wongv@cuhk.edu.hk, geoPoint lat: 22.38333, lon: 114.18333, locations facility: Fundació de Recerca Clinic Barcelona, city: Barcelona, country: Spain, contacts name: Isabel Graupera, PhD, role: CONTACT, email: igraupera@hsph.harvard.edu, geoPoint lat: 41.38879, lon: 2.15899, locations facility: University of Seville, city: Sevilla, zip: 41004, country: Spain, contacts name: Manuel R Gómez, PhD, role: CONTACT, email: mromerogomez@us.es, geoPoint lat: 37.38283, lon: -5.97317, locations facility: University of Edinburgh, city: Edinburgh, state: Scotland, country: United Kingdom, contacts name: Jonathan Fallowfield, PhD, role: CONTACT, email: Jonathan.Fallowfield@ed.ac.uk, contacts name: Timothy Kendall, PhD, role: CONTACT, email: Tim.Kendall@ed.ac.uk, geoPoint lat: 55.95206, lon: -3.19648, locations facility: University of Edinburgh, city: Edinburgh, state: Scotland, country: United Kingdom, contacts name: Quentin Anstee, PhD, role: CONTACT, email: quentin.anstee@newcastle.ac.uk, contacts name: Jo Boyle, role: CONTACT, email: jo.boyle@newcastle.ac.uk, geoPoint lat: 55.95206, lon: -3.19648, locations facility: Imperial College London, city: London, country: United Kingdom, contacts name: Pinelopi Manousou, PhD, role: CONTACT, email: p.manousou@imperial.ac.uk, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False