Digital Pathology and AI for Liver Outcomes in MASLD (DPAILO-1)

PharmaNest

Status: Not yet enrolling

Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06344364

PHN 1-080-23

Details and patient eligibility

About

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).

Full description

MASH, or metabolic dysfunction-associated steatohepatitis, presents histological liver changes resembling those caused by alcohol abuse, but in the absence of alcohol intake. Common among adults with conditions like obesity and type-2 diabetes, MASH, especially its severe form, is anticipated to become a leading cause of end-stage liver disease.

Currently lacking approved treatments, MASH poses a significant burden on liver health and transplantation. Diagnosis and assessment rely on subjective histological review, prone to variability and limitations in detecting subtle changes. Consequently, there's an urgent need for accurate, continuous histological biomarkers.

The FibroNest Ph-FCS offers a promising solution, utilizing high resolution digital pathology and sophisticated algorithmic methods for sensitive and reproducible fibrosis severity assessment and prediction of clinical events. In a 2003 proof of concept retrospective study on 400 patients, its prognostic performance was excellent.

In this proposed multi-center retrospective study, we aim to confirm the Ph-FCS's prognostic value on a large cohort of 1,700 MASLD patients. We will also compare the prognostic performance of the Ph-FCS with the prognostic performance of the NASH-CR Fibrosis stages, and with non-invasive biomarkers like Fib-4 and elastography/Fibroscan, also collected retrospectively from the point of initial diagnosis.

This study seeks to:

(i) Confirm Ph-FCS's prognostic utility on a large scale.

(ii) Compare biopsy-based Ph-FCS with NASH-CRN F Stages

(iii) Compare biopsy-based Ph-FCS with non-invasive biomarkers.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult pts ( >=18 years old) with MASLD defined histologically.
• Liver biopsy with fibrosis stains available for digitization or already digitized.
• Clinical follow-up >1 year available recording liver-related outcomes either through hospitalization ICD-10 codes or through clinical observation

Exclusion criteria

• Liver diseases other than MASLD Note: no exclusion based on bariatric surgery, significant weight loss or enrollment in NASH clinical studies, but data is collected for data analysis / competing effects (see data analysis plan)

Trial design

1,800 participants in 2 patient groups

Non-Liver Related Event

Description:

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

Treatment:

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

Liver Related Event

Description:

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

Treatment:

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