跳至主要内容
临床试验/NCT00963248
NCT00963248已完成不适用

Surveillance of EBV Infection as a Risk Factor for PTLD in Pediatric and Adult Renal Transplant Recipients - a Multicenter Prospective Study

Klinik für Kinder- und Jugendmedizin1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2003年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
1
主要终点
EB viral load, serology and EBV-specific T cell in pediatric (and adult) renal transplant recipients with or without clinical symptoms of EBV, PTLD etc.

研究概览

简要总结

Question:

In which stage of an EBV-infection is a selective reduction of immunosuppressive medication reasonable to minimize the risk for PTLD, without putting the transplant recipient at risk of acute rejection episodes due to under immunosuppression?

Aim of study:

Identification of patients at high-risk for PTLD.

详细描述

PTLD represents a heterogeneous group of abnormal lymphoid proliferations, generally of B-cells, that occur in the setting of ineffective T-cell function because of pharmacological immunosuppression. Because the vast majority of PTLDs are associated with Epstein-Barr virus (EBV) infection, surveillance of EBV infection may have the potential to prevent the development of PTLD by early intervention. However, the cut-off values of "high" EBV viral load remain badly defined due to a lack of prospective studies and assay standardization. The aim of this ongoing multicenter prospective study is the serial detection of primary EBV infection or reactivation in a homogeneous patient population of pediatric renal transplant recipients during the first 2 years posttransplant by the combined analysis of quantitative EBV viral load by a standardized quantitative PCR technique, EBV serology and EBV-specific T-lymphocytes for the identification of high-risk patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • male and female pediatric and adult renal transplant recipients with written informed consent

排除标准

  • psychological illness which does not allow patient to understand the study and participate following his own free will
  • no written informed consent

结局指标

主要结局

EB viral load, serology and EBV-specific T cell in pediatric (and adult) renal transplant recipients with or without clinical symptoms of EBV, PTLD etc.

时间窗: 9 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. med. Britta Hoecker

EBV in pediatric RTx patients

Klinik für Kinder- und Jugendmedizin

研究点 (1)

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