Metabolic Dysfunction-associated Steatotic Liver DiseaseNCT06493253
Digital Pathology and AI for Liver Outcomes in MASLD (DPAILO-2)
An observational study of Metabolic Dysfunction-associated Steatotic Liver Disease, run by PharmaNest, Inc at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Metabolic Dysfunction-associated Steatotic Liver Disease
- What is being tested?
- Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS)
- How many people
- 1,519 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 15 Mar 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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
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- 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
- Vascular lesions
- Iron overload greater than 3+
- Zones of confluent necrosis, infarction, massive or sub-massive, pan-acinar necrosis
- Multiple epithelioid granulomas
- Congenital hepatic fibrosis
- Polycystic liver disease
- Other metabolic or congenital liver disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23284
About this study
Official title: Epidemiologic Liver Outcomes Retrospective Study to Confirm The Prognostic Value of the FibroNest Digital Pathology Fibrosis Biomarker (Ph-FCS) in Patients With MASLD (DPAILO-2)
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).
Read the detailed description
MASH (Metabolic Dysfunction-Associated Steatohepatitis):
MASH presents histological liver changes similar to those caused by alcohol abuse, but occurs in the absence of alcohol intake. It is common among adults with conditions such as obesity and type-2 diabetes. Severe MASH is expected to become a leading cause of end-stage liver disease.
Current Challenges:
There are currently no fully approved treatments for MASH which places a significant burden on liver health and transplantation. Diagnosis and assessment rely on subjective histological reviews, which are prone to variability and limitations in detecting subtle changes. Therefore, there is an urgent need for accurate and continuous histological biomarkers.
FibroNest Ph-FCS Solution:
The FibroNest Ph-FCS offers a promising solution by 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, the Ph-FCS demonstrated excellent prognostic performance.
Proposed Study:
This multi-center retrospective study aims to confirm the Ph-FCS's prognostic value using patient liver biopsies and clinical outcome data from the NAFLD Adult Database 2 registry (NCT01030484). The prognostic performance of the Ph-FCS will be compared to:
- The NASH-CRN Histological Fibrosis Stages established from the same biopsies.
- Non-invasive biomarkers like Fib-4 and elastography/Fibroscan, also collected retrospectively from the point of initial diagnosis.
Study Objectives:
(i) Confirm the Ph-FCS's prognostic utility on a large scale. (ii) Compare the Ph-FCS's prognostic performance with that of the NASH-CRN Fibrosis Stages established from the same biopsies.
(iii) Compare biopsy-based Ph-FCS with non-invasive biomarkers.
- Being tested
- Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS)
- Keywords
- MASH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Non-Liver Related Event | Absence of any of the liver events described in the second group in the patient clinical follow-up. Receives: 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. Receives: Diagnostic Test: Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time-to-event analysis between 2 and 10 years
Secondary outcomes (3)
Performance of Hepatic Decompensation Event predictive value of the NASH-CRN Fibrosis Stage
Area under Receiver Operating Characteristic Curve (AUROC) of the NASH-CRN Fibrosis Stage, as a prognostic/diagnostic biomarker for liver related events in patients with MASH.
Measured: Time-to-event analysis between 2 and 10 years
Performance of Hepatic Decompensation Event predictive value of available non-invasive biomarkers (NITs) including Fib-4 and Elastography by measured by Fibroscan
Area under Receiver Operating Characteristic Curve (AUROC) of the NIT biomarkers, as a prognostic/diagnostic biomarker for liver related events in patients with MASH.
Measured: Time-to-event analysis between 2 and 10 years
Performance of Hepatic Decompensation Event predictive value of the Collagen Area Ratio (CAR%) as measured by FibroNest
Area under Receiver Operating Characteristic Curve (AUROC) of the FibroNest CAR%, as a prognostic/diagnostic biomarker for liver related events in patients with MASH.
Measured: Time-to-event analysis between 2 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Sep 2025
- Primary completion15 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic Dysfunction-associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,519 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaNest, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nonalcoholic Steatohepatitis Clinical Research Network (NASH), Virginia Commonwealth University
- Responsible party
- Sponsor
- Investigators
- Arun J Sanyal, MD, Principal investigator, Virginia Commonwealth UniversityCynthia Belhling, MD, Study director, University California San DiegoDavid E Kleiner, MD. PhD, Study director, Nonalcoholic Steatohepatitis Clinical Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493253
- Sponsor's protocol ID
- PHN 1-020-24
- Status last verified
- Aug 2026
- First submitted
- 2 Jul 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34670043Ratziu 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