Correlation of Blood Gene Expression (TruGraf Liver) With Liver Biopsy in Pediatric Liver Transplant Recipients

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.

Study Overview

• Status: Terminated
• Conditions: Liver Failure, Acute; Liver Transplant; Complications
• Intervention / Treatment: Diagnostic test: TruGraf® Liver gene expression panel (GEP)

Detailed Description

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 (Actual): 16

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric Liver Transplant

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Collaborators: Eurofins
• Investigators: Principal Investigator: Ryan Fischer, MD, Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): February 7, 2025
• Study Completion (Actual): February 7, 2025

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Pediatric
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hepatic Insufficiency; Liver Failure; Liver Failure, Acute
• Other Study ID Numbers: 00002826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No