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

Liver Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06263114
• Other study ID #: 00002826
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: February 2024
• Source: Children's Mercy Hospital Kansas City
• Contact: Corey Schurman, MA
• Phone: 8163023076
• Email: crschurman[@]cmh.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Liver Failure
• Liver Failure, Acute
• Liver Transplant; Complications

Intervention

Diagnostic Test:
• TruGraf® Liver gene expression panel (GEP)
Test done on blood sample collected during for cause or routine liver biopsy

Locations

Country	Name	City	State
United States	Children's Mercy Hospitals and Clinics	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	Eurofins

Country where clinical trial is conducted

United States, 

Outcome

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