NCT00514345Unknown不适用
CYP3A5 Genotype as a Potential Risk Factor for the Development of Ifosamide Nephrotoxicity in Children
Children's Cancer and Leukaemia Group20 个研究点 分布在 2 个国家目标入组 300 人开始时间: 2007年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 20
- 主要终点
- CYP3A5 genotype
研究概览
简要总结
RATIONALE: Studying the genes expressed in samples of blood from young patients with cancer treated with ifosfamide may help doctors identify risk factors for kidney damage.
PURPOSE: This clinical trial is looking at the CYP3A5 gene to see if having the gene may be a risk factor for kidney damage in young patients with cancer treated with ifosfamide.
详细描述
OBJECTIVES:
Primary
- To determine the CYP3A5 genotype in young patients with cancer who have received ifosfamide.
- To document renal function and nephrotoxicity on one occasion between 1 month and 5 years after completion of ifosfamide treatment.
- To determine the relationship between CYP3A5 genotype and ifosfamide nephrotoxicity.
Secondary
- To compare the measured glomerular filtration rate (GFR) (using a radioisotope clearance method) with that calculated using the Cole (weight and creatinine) model.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- — 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
CYP3A5 genotype
Renal function and nephrotoxicity
Relationship between CYP3A5 genotype and ifosfamide nephrotoxicity
次要结局
- Comparison of measured glomerular filtration rate (GFR) with the Cole model
研究者
研究点 (20)
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