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临床试验/NCT03529760
NCT03529760Unknown不适用

Chemotherapy Efficacy and Follow-up Study of Hepatitis B Virus Infection and Reactivation in Children With Leukemia

Children's Hospital of Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2018年5月8日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
600
试验地点
1
主要终点
HBV-DNA positive

研究概览

简要总结

Children with clinically diagnosed leukemia may experience occult HBV infection after chemotherapy immunosuppressive therapy, which may affect the normal course of leukemia treatment. However, this is not caused by clinically relevant diagnosis and treatment measures but exists in vivo.

详细描述

The clinical diagnosis of children with leukemia may be due to the influence of leukemia disease on the immune cells of the children and the damage to the immune system due to immunosuppressive therapy in children. Therefore, the risk of contracting hepatitis B virus is relatively high, and some children are In the treatment of immunosuppressive chemotherapy (later), the reactivation of occult HBV infection has an impact on the normal course of leukemia treatment. However, this is not a clinically relevant diagnosis and treatment measure. It is necessary to avoid unnecessary conflicts between clinical doctors and patients as much as possible.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
1 Year 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The clinical diagnosis of children with leukemia received systemic chemotherapy.

排除标准

  • Children with non-leukemia and children without appropriate treatment.

结局指标

主要结局

HBV-DNA positive

时间窗: 1-year

Positive HBV nucleic acid test

次要结局

未报告次要终点

研究者

发起方
Children's Hospital of Chongqing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Qiu Li

Director

Children's Hospital of Chongqing Medical University

研究点 (1)

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