Status:
NOT_YET_RECRUITING
Digital Pathology and AI for Liver Outcomes in MASLD (DPAILO-2)
Lead Sponsor:
PharmaNest, Inc
Collaborating Sponsors:
Nonalcoholic Steatohepatitis Clinical Research Network (NASH)
Virginia Commonwealth University
Conditions:
Metabolic Dysfunction-associated Steatotic Liver Disease
Eligibility:
All Genders
18-90 years
Brief 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 f...
Detailed Description
MASH (Metabolic Dysfunction-Associated Steatohepatitis): MASH presents histological liver changes similar to those caused by alcohol abuse, but occurs in the absence of alcohol intake. It is common a...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
1700 Patients enrolled
Trial Details
Trial ID
NCT06493253
Start Date
September 1 2025
End Date
March 1 2026
Last Update
August 5 2025
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23284