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).
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.
Study Type
OBSERVATIONAL
Enrollment
1,800
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 score that aggregates quantitative histological features of fibrosis severity measured by high resolution quantitative image analysis.
The Chinese University of Hong Kong
Shatin, Hong Kong
Fundació de Recerca Clinic Barcelona
Barcelona, Spain
University of Seville
Seville, Spain
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 frame: Time-to-event analysis between 2 and 10 years
Performance of Hepatic Decompensation Event predictive value of the NASH-CRN Fibrosis Stage, a biopsy-based score for fibrosis severity
Area under Receiver Operating Characteristic Curve (AUROC) of NASH-CRN F stage, as a biopsy-based prognostic/diagnostic biomarker for Hepatic Decompensation Events in patients with MASH.
Time frame: Time-to-event analysis between 2 and 10 years
Performance of Hepatic Decompensation Event predictive value of the FIB-4 biomarker, a non-invasive test
Area under Receiver Operating Characteristic Curve (AUROC) of FIB-4, as a prognostic/diagnostic biomarker for Hepatic Decompensation Events in patients with MASH.
Time frame: 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
Area under Receiver Operating Characteristic Curve (AUROC) of elastography, as a prognostic/diagnostic biomarker for Hepatic Decompensation Events in patients with MASH.
Time frame: Time-to-event analysis between 2 and 10 years
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