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

CompletedN/A

Sponsor: PharmaNest, Inc

Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease

Interventions: Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS)

Countries: United States

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 90 Years

Study type: OBSERVATIONAL

Eligibility criteria

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, infarction, massive or sub-massive, pan-acinar necrosis
* Multiple epithelioid granulomas
* Congenital hepatic fibrosis
* Polycystic liver disease
* Other metabolic or congenital liver disease

Locations (1)

Richmond, Virginia, United States