Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557564
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Diagnosis of Graft Pathology by TruGraf
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development of a Machine Learning Tool for Non-invasive Diagnosis of Liver Graft Pathology Using TruGraf
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to to identify different causes of liver diseases or damage in liver transplant patients and develop a machine learning algorithm as a non-invasive tool leveraging gene expression and patient clinical information to classify transplant liver diseases We will collect blood samples of the participants who had undergone or will undergo the liver biopsy as part of standard of care and use this blood in TruGarf TruGraf is a non-invasive test that measures differentially expressed genes in the blood of transplant recipients to rule out liver damage Researcher will collect the biopsy result from the medical record and this will be compared with the TruGarf results
Detailed Description:
Given the significant investment of healthcare resources into transplantation it is critical to identify recipients with graft pathologies such as Acute Cellular Rejection ACR NASH cholestasis etc at an earlier stage to implement the appropriate intervention rather than initiating empiric treatment that could be unsafe This project will develop a practical Machine learning-based tool based on the results of the TruGraf assay alongside clinical and laboratory data for non-invasive diagnosis of graft pathology TruGraf is a non-invasive test that measures differentially expressed genes in the blood of transplant recipients to identify patients who are likely to be adequately immunosuppressed and in doing so rule out graft damage TruGraf measures the difference in gene expression for a precise panel of specific genes that have been empirically determined to discriminate between allografts that are truly healthy Non-ACR and those in transplant patients that have acute rejection on biopsy AR Nevertheless the exact etiology of graft damage may be difficult to discern for the transplant clinician The clinical characteristics and history of the liver transplant recipient as well as liver enzyme patterns can provide a pre-test probability of one diagnosis being more likely than the other Acute cellular rejection NASH biliary or viral disease The proposed tool will leverage our expertise in Machine Learning tools applied to clinical and molecular data TruGraf assay results to enable effective clinical implementation of the TruGraf assay
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