Liver transplant rejection is when the body's immune system attacks and damages the liver of a transplant recipient. Currently the best way to see if that is happening is with a liver biopsy. The purpose of this research study is to see if a simple blood test can diagnose if a transplanted liver is being rejected.
This study is an investigator-initiated, prospective, single-cohort trial to assess the ability of the TruGraf® Liver gene expression panel (GEP) to predict rejection in pediatric liver transplant recipients undergoing surveillance and for-cause liver biopsy.
Study Type
OBSERVATIONAL
Enrollment
16
Test done on blood sample collected during for cause or routine liver biopsy
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States
Correlation of the TruGraf® Liver GEP with rejection activity index (RAI) on surveillance and for-cause biopsy.
To evaluate the performance of the blood-based TruGraf® Liver GEP to accurately diagnose rejection, confirmed by surveillance or for-cause liver biopsy.
Time frame: Week prior to or at time of biopsy
Comparison of the GEP to non-rejection injury found on biopsy
A comparison of the GEP to non-rejection injury (e.g., infection) found on biopsy
Time frame: Week prior to or at time of biopsy
Utility of the GEP for monitoring liver injury
Utility of the GEP for monitoring liver injury (i.e., as treatment is weaned, does the GEP return to a non-rejection correlate).
Time frame: Week prior to or at time of biopsy
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