NCT02986620已完成不适用
Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 388
- 试验地点
- 24
- 主要终点
- Number of patients with the IDH mutations in AML at initial diagnosis.
研究概览
简要总结
This is a study where there are no interventions planned. Investigators will only collect data already in the patient's history and analyze it. Particularly, we are interested in molecular data from AML patients.
This means that patients will follow their regular diagnostic and clinical practice. The analyses will be conducted according to the routine diagnostic and clinical practice as well and no additional blood withdrawal will be performed.
详细描述
The study will be conducted as follows:
- Retrospective phase clinical and molecular data of patients analyzed for IDH1/2 mutations will be retrospectively collected in the centers that have already introduced IDH1/2 mutational screening in their practice from cases collected according to standard procedure (Ficoll and lysis in RLT buffer).
- Prospective phase: each participating center already performing IDH1/2 mutational status on samples of their AML patients at diagnosis or relapse - on freshly isolate mononuclear cells from bone marrow and/or peripheral blood using Ficoll density gradient preparation - will prospectively collect the clinical and molecular data.
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
- 18 Years 至 —（Adult, Older 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
Number of patients with the IDH mutations in AML at initial diagnosis.
时间窗: At two years from study entry.
Number of patients with the IDH mutations in AML at relapse.
时间窗: At three years from study entry.
次要结局
未报告次要终点
研究者
研究点 (24)
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