Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344364
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-03-27
Brief Title:
Digital Pathology and AI for Liver Outcomes in MASLD
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-1
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
DPAILO-1
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 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 theres 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-FCSs prognostic value on a large cohort of 1700 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 elastographyFibroscan also collected retrospectively from the point of initial diagnosis
This study seeks to
i Confirm Ph-FCSs 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
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 theres 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-FCSs prognostic value on a large cohort of 1700 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 elastographyFibroscan also collected retrospectively from the point of initial diagnosis
This study seeks to
i Confirm Ph-FCSs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None