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

NCT06263114 | Terminated

• 1 other identifier: 00002826
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplant; Complications; Liver Failure, Acute

Keywords

Pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison of the GEP to non-rejection injury found on biopsy

  Week prior to or at time of biopsy

• Utility of the GEP for monitoring liver injury

  Week prior to or at time of biopsy

Interventions

TruGraf® Liver gene expression panel (GEP) DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric Liver Transplant

You may qualify if:

• All liver transplant patients at least 1 year of age and less than 18 years of age undergoing surveillance or for-cause liver biopsy

You may not qualify if:

• Non-English, non-Spanish Speaking

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• Eurofins: collaborator

Study Sites (1)

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Liver Failure, Acute

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Ryan Fischer, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Section of Hepatology and Transplant Medicine

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 16, 2024
• Study Start: January 1, 2024
• Primary Completion: February 7, 2025
• Study Completion: February 7, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)