NCT04242849已完成不适用
IDH1/2 Mutational Analysis in AML Patients: Diagnosis and Follow-up
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 354
- 主要终点
- Presence of IDH1/2 mutation
研究概览
简要总结
In a spanish series of AML patients it is intended to perform, at the moment of diagnosis, pyrosequencing of IDH1 and IDH2 genes. Taking into account the incidence of AML in the area, it is planed to study 100 patients per year.
Among the cases with IDH1/2 mutations, targeted deep sequencing (TDS) of a panel covering coding regions of 40 myeloid related genes will be applied. With TDS, pyrosequencing results will be validated at the same time that prognosis value of co-mutated genes could be studied. Furthermore, with TDS, molecular architecture of IDH1 and IDH2 mutated cases might be better understood.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >18 years old with de novo acute myeloid leukemia will be included. All patients will be treated according to clinical routine.
排除标准
- •Patients not following the above criteria.
结局指标
主要结局
Presence of IDH1/2 mutation
时间窗: 1 day
Detection of mutations in IDH1 and IDH2 genes
次要结局
- Detection of co-mutations(1 day)
研究者
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