Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493253
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-02
Brief Title:
Digital Pathology and AI for Liver Outcomes in MASLD DPAILO-2
Sponsor:
PharmaNest Inc
Organization:
PharmaNest Inc
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 with metabolic dysfunction-associated steatohepatitis MASH
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-FCSs 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
1 The NASH-CRN Histological Fibrosis Stages established from the same biopsies
2 Non-invasive biomarkers like Fib-4 and elastographyFibroscan also collected retrospectively from the point of initial diagnosis
Study Objectives
i Confirm the Ph-FCSs prognostic utility on a large scale ii Compare the Ph-FCSs 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
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-FCSs 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
1 The NASH-CRN Histological Fibrosis Stages established from the same biopsies
2 Non-invasive biomarkers like Fib-4 and elastographyFibroscan also collected retrospectively from the point of initial diagnosis
Study Objectives
i Confirm the Ph-FCSs prognostic utility on a large scale ii Compare the Ph-FCSs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None