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Diagnosis of Graft Pathology by TruGraf

N/A
Recruiting
Led By Mamatha Bhat, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Develop and validate a ML-based algorithm
Secondary study objectives
Identify specific etiologies of ongoing graft damage

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Liver Transplant patient will be undergoing liver graft biopsy.Experimental Treatment1 Intervention
Liver transplant patients will be undergoing liver graft biopsy (for any reason), or have had a liver biopsy within 48 hours of consent.

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Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,531 Previous Clinical Trials
503,851 Total Patients Enrolled
Transplant Genomics, Inc.Industry Sponsor
15 Previous Clinical Trials
4,350 Total Patients Enrolled
Mamatha Bhat, MDPrincipal InvestigatorUHN
2 Previous Clinical Trials
142 Total Patients Enrolled
~314 spots leftby Jul 2027
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