Correlation of Blood Gene Expression (TruGraf Liver) With Liver Biopsy in Pediatric Liver Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Correlation of the TruGraf® Liver GEP with rejection activity index (RAI) on surveillance and for-cause biopsy.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All liver transplant patients at least 1 year of age and less than 18 years of age undergoing surveillance or for-cause liver biopsy
排除标准
- •Non-English, non-Spanish Speaking
结局指标
主要结局
Correlation of the TruGraf® Liver GEP with rejection activity index (RAI) on surveillance and for-cause biopsy.
时间窗: 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.
次要结局
- Utility of the GEP for monitoring liver injury(Week prior to or at time of biopsy)
- Comparison of the GEP to non-rejection injury found on biopsy(Week prior to or at time of biopsy)
研究者
Ryan Fischer, MD
Chief, Section of Hepatology and Transplant Medicine
Children's Mercy Hospital Kansas City