NCT06493253Completed
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)
Source: ClinicalTrials.gov · Last updated 21 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
- 1519 (actual)
- First submitted
- 2 Jul 2024
- Start date
- 1 Sept 2025
- Primary completion date
- 15 Mar 2026
- Lead sponsor
- PharmaNest, Inc
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06493253
What you commit to
- Study type: Observational
- Participants enrolled: 1519
- From 1 Sept 2025 to the primary completion date, 15 Mar 2026
- 1 site in 1 country
- 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.
Prior treatment
- Biliopancreatic diversion or bariatric surgery
Other illness
- Clinical or histological evidence of alcoholic liver disease or alcohol consumption during the two years before entry (\> 20g/day for men, \>10g/day women)
- History of total parenteral nutrition
- History of gastric or jejunoileal bypass preceding the diagnosis of NAFLD
- Evidence of advanced liver disease with Child-Pugh-Turcotte score equal to or greater than 10
- Short bowel syndrome
- Positive for HIV
- Evidence of HBV or HCV infection
- Wilson's disease
- Known glycogen storage disease, dysbetalipoproteinemia, phenotypic hemochromatosis
- Polycystic liver disease
- Other metabolic or congenital liver disease
Other
- From NCT01030484
- Suspected or confirmed hepatocellular carcinoma
- Low alpha-1-antitrypsin level and ZZ phenotype
- Vascular lesions
- Iron overload greater than 3+
- Zones of confluent necrosis, infarction, massive or sub-massive, pan-acinar necrosis
- Multiple epithelioid granulomas
- Congenital hepatic fibrosis
Criteria the registry did not label
- From NCT01030484:
- Age at least 18 years during the consent process
- Willingness to be in the study for 1 or more years
- Ability and willingness to give written, informed consent to be screened for and, if eligible, to be enrolled into the Database 2 study
- Minimal or no alcohol use history consistent with NAFLD (see exclusion criteria)
- Collection of a liver biopsy that is obtained within 120 days of enrollment as part of standard of care or for evaluation in FLINT trial
- Collection of biosamples (serum, plasma, DNA, and, if available, liver tissue) within 90 days prior to enrollment and 0-90 days before or 4-90 days after the standard of care liver biopsy
Age in the registry: 18 years to 90 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.