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Recruiting NCT06557564

Diagnosis of Graft Pathology by TruGraf

Trial Parameters

Condition Acute Graft Rejection
Sponsor University Health Network, Toronto
Study Type OBSERVATIONAL
Phase N/A
Enrollment 471
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-07-20
Completion 2027-07-20
Interventions
TruGraf liver gene expression

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.

Eligibility Criteria

Inclusion Criteria: 1. . Single-organ Liver transplant recipients 2. Male or female, age \> 18 years at the time of signing informed consent. 3. Willing and able to provide informed consent. 4. Patients will be undergoing liver graft biopsy (for any reason), or have had a liver biopsy within 48 hours of consent. Exclusion Criteria: 1. Repeat transplant 2. Recipient of multi organ transplantation 3. Any treatment for graft rejection such as IV steroids has been given before biopsy. 4. Targeted biopsies for diagnosis of malignancy.

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