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

NCT06493253 | Completed

• 1 other identifier: PHN 1-020-24
• Study Type: observational
• Target: 1,578
• Locations: 1 country
• Sites: 1

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 from standard digital pathology liver biopsy images, in predicting clinical hepatic decompensation events in patients with metabolic dysfunction-associated steatohepatitis (MASH).

Conditions

Metabolic Dysfunction-associated Steatotic Liver Disease

Keywords

MASH

Outcome Measures

Primary Outcomes (1)

• Performance of Hepatic Decompensation Event predictive value of the FibroNest Ph-FCS

  Area under Receiver Operating Characteristic Curve (AUROC) of the FibroNest Ph-FCS, as a prognostic/diagnostic biomarker for liver related events in patients with MASH.

  Time-to-event analysis between 2 and 10 years

Secondary Outcomes (2)

• Performance of Hepatic Decompensation Event predictive value of the NASH-CRN Fibrosis Stage

  Time-to-event analysis between 2 and 10 years

• Performance of Hepatic Decompensation Event predictive value of the elastography (Fibroscan) biomarker, a non-invasive test

  Time-to-event analysis between 2 and 10 years

Study Arms (2)

Non-Liver Related Event

Absence of any of the liver events described in the second group in the patient clinical follow-up.

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

Liver Related Event

Liver-related events include liver-related death, hepatic decompensation events (variceal hemorrhage, ascites, hepatic encephalopathy), and hepatocellular carcinoma.

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

Interventions

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

Biomarker name: FibroNest Phenotypic Fibrosis Composite Score Acronym: FibroNest Ph- FCS Type of Biomarker: Histologic based, Digital, Quantitative Image Analysis, Imaging modality Definition: A quantitative, normalized (no unit) and continuous composite

Liver Related Event; Non-Liver Related Event

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient from the NAFLD Adult Database 2 Registry including Adult pts ( \>=18 years old) with MASLD defined histologically with \>1 year of clinical follow up and available recording liver-related outcomes through clinical observation.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• PharmaNest, Inc: lead
• Nonalcoholic Steatohepatitis Clinical Research Network (NASH): collaborator
• Virginia Commonwealth University: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

Related Publications (2)

• Sanyal AJ, Van Natta ML, Clark J, Neuschwander-Tetri BA, Diehl A, Dasarathy S, Loomba R, Chalasani N, Kowdley K, Hameed B, Wilson LA, Yates KP, Belt P, Lazo M, Kleiner DE, Behling C, Tonascia J; NASH Clinical Research Network (CRN). Prospective Study of Outcomes in Adults with Nonalcoholic Fatty Liver Disease. N Engl J Med. 2021 Oct 21;385(17):1559-1569. doi: 10.1056/NEJMoa2029349.

  PMID: 34670043 BACKGROUND

• Ratziu V, Chen L, Petitjean L. et al. Novel Artificial Intelligence-Assisted Digital Pathology Quantitative Image Analysis Predicts the occurrence of Liver-related Clinical Events in the Multicentric, European, Hepatic Outcomes and Survival Fatty Liver Registry (HITSURFR) Study. Hepatology. 78(S1) S1-S2154 2084-A

  BACKGROUND

Study Officials

• Arun J Sanyal, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• Cynthia Belhling, MD

  University California San Diego

  STUDY DIRECTOR

• David E Kleiner, MD. PhD

  Nonalcoholic Steatohepatitis Clinical Research Network

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 9, 2024
• Study Start: September 1, 2025
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)