Liver Transplant; Complications Clinical Trial
Official title:
Correlation of Blood Gene Expression (TruGraf Liver) With Liver Biopsy in Pediatric Liver Transplant Recipients
NCT number | NCT06263114 |
Other study ID # | 00002826 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2024 |
Est. completion date | January 1, 2027 |
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.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | January 1, 2027 |
Est. primary completion date | January 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 17 Years |
Eligibility | Inclusion Criteria: • All liver transplant patients at least 1 year of age and less than 18 years of age undergoing surveillance or for-cause liver biopsy Exclusion Criteria: • Non-English, non-Spanish Speaking |
Country | Name | City | State |
---|---|---|---|
United States | Children's Mercy Hospitals and Clinics | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Children's Mercy Hospital Kansas City | Eurofins |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Week prior to or at time of biopsy | |
Secondary | 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 | Week prior to or at time of biopsy | |
Secondary | 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). | Week prior to or at time of biopsy |
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