NCT06344364Completed
Digital Pathology and AI for Liver Outcomes in MASLD
Epidemiologic Liver Outcomes Retrospective Study to Confirm The Prognostic Value of the FibroNest Digital Pathology Fibrosis Biomarker (Ph-FCS) in Patients With MASLD (DPAILO-1)
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1241 (actual)
- First submitted
- 27 Mar 2024
- Start date
- 1 Sept 2025
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- PharmaNest, Inc
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06344364
What you commit to
- Study type: Observational
- Participants enrolled: 1241
- From 1 Sept 2025 to the primary completion date, 1 Jun 2026
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Liver diseases other than MASLD Note: no exclusion based on bariatric surgery, significant weight loss or enrollment in NASH clinical studies, but data is collected for data analysis / competing effects (see data analysis plan)
Who the study is looking for
- Adult pts ( \>=18 years old) with MASLD defined histologically.
- Liver biopsy with fibrosis stains available for digitization or already digitized.
- Clinical follow-up \>1 year available recording liver-related outcomes either through hospitalization ICD-10 codes or through clinical observation
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundació de Recerca Clínic Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| University of Seville Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| The Chinese University of Hong Kong Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.