Study Results
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Basic Information
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NOT_YET_RECRUITING
1800 participants
OBSERVATIONAL
2025-09-01
2026-03-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Non-Liver Related Event
Absence of any of the liver events described in the second group in the patient clinical follow-up.
Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS)
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.
Liver Related Event
Liver-related events include liver-related death, hepatic decompensation events (variceal hemorrhage, ascites, hepatic encephalopathy), and hepatocellular carcinoma.
Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS)
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.
Interventions
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Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
University of Seville
OTHER
Fundacio Clinic Barcelona
OTHER
Sorbonne University
OTHER
PharmaNest, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Vlad Ratziu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sorbonne University
Locations
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The Chinese University of Hong Kong
Shatin, , Hong Kong
Fundació de Recerca Clinic Barcelona
Barcelona, , Spain
University of Seville
Seville, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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
Other Identifiers
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PHN 1-080-23
Identifier Type: -
Identifier Source: org_study_id
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