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| Name | Class |
|---|---|
| Chinese University of Hong Kong | OTHER |
| University of Seville | OTHER |
| Fundacio Clinic Barcelona | OTHER |
| Sorbonne University |
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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 1,200 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Liver Related Event | Absence of any of the liver events described in the second group in the patient clinical follow-up. |
| |
| Liver Related Event | Liver-related events include liver-related death, hepatic decompensation events (variceal hemorrhage, ascites, hepatic encephalopathy), and hepatocellular carcinoma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 score that aggregates quantitative histological features of fibrosis severity measured by high resolution quantitative image analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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-to-event analysis between 2 and 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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Adult pts ( >=18 years old) with MASLD defined histologically with >1 year of clinical follow up and available recording liver-related outcomes either through hospitalization ICD-10 codes or through clinical observation.
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| Name | Affiliation | Role |
|---|---|---|
| Vlad Ratziu, MD, PhD | Sorbonne University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Shatin | Hong Kong | ||||
| Fundació de Recerca Clinic Barcelona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37903863 | Background | Kendall TJ, Jimenez-Ramos M, Turner F, Ramachandran P, Minnier J, McColgan MD, Alam M, Ellis H, Dunbar DR, Kohnen G, Konanahalli P, Oien KA, Bandiera L, Menolascina F, Juncker-Jensen A, Alexander D, Mayor C, Guha IN, Fallowfield JA. An integrated gene-to-outcome multimodal database for metabolic dysfunction-associated steatotic liver disease. Nat Med. 2023 Nov;29(11):2939-2953. doi: 10.1038/s41591-023-02602-2. Epub 2023 Oct 30. | |
| 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 | ||
| 34670043 |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D004066 | Digestive System Diseases |
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| OTHER |
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| 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-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-to-event analysis between 2 and 10 years |
| Barcelona |
| Spain |
| University of Seville | Seville | 41004 | Spain |
| Result |
| 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. |