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Clinical Trial Details — Status: Recruiting

Administrative data

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

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
Health authority
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

Study Design


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
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