Single Nucleotide Polymorphisms and Relapse Risk in Standard Risk ALL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Development of veno-occlusive disease in patients on CCG-1952
研究概览
简要总结
This laboratory study is looking at DNA in tumor tissue samples from young patients with acute lymphoblastic leukemia. DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment
详细描述
PRIMARY OBJECTIVE:
I. To validate significant associations between SNPs and treatment outcome and toxicity on Children's Cancer Group (CCG)-1891 on an independent sample set from a successor CCG study for standard risk acute lymphoblastic leukemia (ALL), CCG-1952.
II. To evaluate the role of SNPs in drug metabolizing enzymes and the development of veno-occlusive disease in patients on CCG-1952.
III. To evaluate interactions among genotypes and other risk factors for treatment response in a combined data set of CCG-1891 and CCG-1952 with recently developed analytic tools for high dimensional data.
IV. To develop predictive models utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment response and toxicity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in clinical trial CCG-1891 or CCG-1952 with pediatric ALL
排除标准
- 未提供
结局指标
主要结局
Development of veno-occlusive disease in patients on CCG-1952
时间窗: Day 28
Classification and Regression Trees (CART), genotype patterning, Multifactor Dimensionality Reduction (MDR) techniques will be used to identify SNP combinations associated with risk of relapse and VOD
Development of a predictive model of leukemia relapse
时间窗: Day 28
Predictive models will be developed utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment response
Leukemia Relapse
时间窗: Day 7
Contingency tables will be used to tabulate the relationship between relapse and genotype, race, leukemia cytogenetics, day 7 bone marrow status, and treatment arm
Development of a predictive model of leukemia toxicity
时间窗: Day 28
Predictive models will be developed utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment toxicity.
次要结局
- Development of grade III/IV toxicity as defined by the CCG toxicity criteria(Day 28)