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

NCT ID: NCT06263114

Last Updated: 2025-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-02-07

Brief Summary

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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

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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.

Conditions

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Liver Transplant; Complications Liver Failure, Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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TruGraf® Liver gene expression panel (GEP)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eurofins

INDUSTRY

Sponsor Role collaborator

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Ryan Fischer, MD

Chief, Section of Hepatology and Transplant Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ryan Fischer, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Locations

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Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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00002826

Identifier Type: -

Identifier Source: org_study_id

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