Pharmacogenetic Analysis of Korean Pediatric Patients With Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To find out distribution of genetic polymorphisms genes related to the pharmacodynamics of the ALL therapy
研究概览
简要总结
This study is to find out distribution of genetic polymorphisms and genes related to the chemotherapeutic drugs of ALL.
详细描述
Cure rate of pediatric ALL dramatically improved over 80%. Resistance to drug and hematologic relapse are remaining problem in ALL treatment. One of the explanations of drug resistance and toxicities is the pharmacogenetic effect. Germline polymorphisms in genes that code for proteins involved in the pharmacokinetics and pharmacodynamics of antileukemic agents are various, and inter-patient variability is the main factor for pharmacogenetic difference. Since multiple chemotherapeutic agents are involved in treating ALL, many genes related to the metabolic pathways of those drugs have an effect on the pharmacokinetics of patients with ALL. In Korea, pharmacogenetic study including multiple genetic loci for pediatric ALL has not been reported.In this study, the distribution of genetic polymorphisms and genes related to antileukemic drugs were analyzed, and their relations to the outcome of treatment and relapse rates were assessed.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute lymphoblastic leukemia
- •In case of informed consent and assent
排除标准
- •Paients or parents refusal
结局指标
主要结局
To find out distribution of genetic polymorphisms genes related to the pharmacodynamics of the ALL therapy
时间窗: up to 3 years from diagnosis
* The distribution of each genetic polymorphism is descriped. * The differences in genetic polymorphism between risk groups (high vs. standard) are analyzed using the chi-square test or Fisher's exact test.
次要结局
- To find out relation of genetic polymorphisms and clinical outcome (relapse or survival)(up to 3 years from diagnosis)
- To see the ethnic difference of genetic polymorphisms related to the chemotehrapeutic drugs of ALL(whenever after diagnosis and genetic analysis (no time frame needed))
- To find out risk factors of relapse and death(up to 3 years from diagnosis)
研究者
Hyo Seop Ahn
MD. Ph D., Professor
Seoul National University Hospital