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Sponsor requested study closure
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| Name | Class |
|---|---|
| Eurofins | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TruGraf® Liver gene expression panel (GEP) | Diagnostic Test | Test done on blood sample collected during for cause or routine liver biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Utility of the GEP for monitoring liver injury |
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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
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Pediatric Liver Transplant
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Fischer, MD | Children's Mercy Hospital Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | United States |
No individual participant data will be available
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 3, 2023 | Jan 8, 2024 |
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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 |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 23, 2023 | Feb 14, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D017114 | Liver Failure, Acute |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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