Digital Pathology and AI for Liver Outcomes in MASLD (DPAILO-2) (NCT06493253) | Clinical Trial Compass
CompletedNot Applicable
Digital Pathology and AI for Liver Outcomes in MASLD (DPAILO-2)
United States1,578 participantsStarted 2025-09-01
Plain-language 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).
Who can participate
Age range18 Years – 90 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Exclusion Criteria:
From NCT01030484
* 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
* Biliopancreatic diversion or bariatric surgery
* Evidence of advanced liver disease with Child-Pugh-Turcotte score equal to or greater than 10
* Short bowel syndrome
* Suspected or confirmed hepatocellular carcinoma
* Positive for HIV
* Evidence of HBV or HCV infection
* Low alpha-1-antitrypsin level and ZZ phenotype
* Wilson's disease
* Known glycogen storage disease, dysbetalipoproteinemia, phenotypic hemochromatosis
* Vascular lesions
* Iron overload greater than 3+
* Zones of confluent necrosis, infarc…
What they're measuring
1
Performance of Hepatic Decompensation Event predictive value of the FibroNest Ph-FCS
Timeframe: Time-to-event analysis between 2 and 10 years