Immune Development in Pediatric Transplantation (CTOTC-02)

This is a multi-center, prospective, observational cohort study in pediatric renal transplant recipients. Target accrual in this study is 75 subjects over 2 years. Enrolled subjects will be categorized based on pre-enrollment CMV and EBV serology testing and be placed in the viral positive group, viral negative group, or split serology group. Subjects in the split serology group will not count towards study accrual target but will be included in analyses. CMV and EBV serology tests obtained for transplant evaluation will be collected retrospectively and used to categorize subjects. Subjects with previously negative serologies but later have positive serology results as indicated by testing on day of transplantation will be placed into the viral positive group. Subjects will have 6 study visits over 12 months as participants in this study.

本研究为一项针对儿童肾移植受者的多中心前瞻性观察队列研究。本研究的目标入组例数为75例受试者，研究周期为2年。入组受试者将根据入组前巨细胞病毒（CMV）与EB病毒（EBV）血清学检测结果进行分类，分为病毒阳性组、病毒阴性组或血清学拆分组。血清学拆分组的受试者不计入研究入组目标例数，但将纳入后续分析。用于移植评估的巨细胞病毒与EB病毒血清学检测将被回顾性收集，并用于受试者分组。对于入组前血清学结果为阴性，但在移植当日检测显示血清学转为阳性的受试者，将被归入病毒阳性组。本研究的受试者将在12个月内完成6次研究访视。