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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06263114

Enrollment

Registered

2024-02-16

Start date

2024-01-01

Completion date

2025-02-07

Last updated

2025-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Failure, Acute, Liver Transplant; Complications

Keywords

Pediatric

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTTruGraf® Liver gene expression panel (GEP)

Test done on blood sample collected during for cause or routine liver biopsy

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Correlation of the TruGraf® Liver GEP with rejection activity index (RAI) on surveillance and for-cause biopsy.	Week prior to or at time of biopsy	To evaluate the performance of the blood-based TruGraf® Liver GEP to accurately diagnose rejection, confirmed by surveillance or for-cause liver biopsy.

Secondary

Measure	Time frame	Description
Comparison of the GEP to non-rejection injury found on biopsy	Week prior to or at time of biopsy	A comparison of the GEP to non-rejection injury (e.g., infection) found on biopsy
Utility of the GEP for monitoring liver injury	Week prior to or at time of biopsy	Utility of the GEP for monitoring liver injury (i.e., as treatment is weaned, does the GEP return to a non-rejection correlate).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026