NCT03402399Unknown不适用
Defining the Molecular Risk in Israeli Patients With Secondary Compared to Primary Myelofibrosis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Rate of patients with one or more HMR mutations in primary compared to secondary (post PV/ET) MF
研究概览
简要总结
The aim of the study is to determine the rate of HMR mutations in PMF and secondary MF (post PV/ET) subjects, and correlate the rate of mutations with clinical features as known prognostic scores.
详细描述
Main inclusion criteria:
- Diagnosis of PMF, post PV MF or post ET MF according to the WHO 2008 classification
- Age ≥ 18 years
- Concurrent participation in clinical trials will be allowed.
Efficacy assessments will be evaluated by: HMR mutations rate, specific HMR mutations, disease duration, presence of splenomegaly, cytogenetic risk, DIPPS, IPSS, ET survival score and PV survival score.
The primary efficacy parameter to be assessed will be HMR mutation rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Diagnosis of PMF, post PV MF or post ET MF according to the WHO 2008 classification
- •Age . 18 years
- •Patient is willing and capable of giving a written informed consent.
- •Concurrent participation in clinical trials will be allowed
排除标准
- •Unwilling or unable to provide informed consent
- •Prefibrotic MF
研究组 & 干预措施
Primary Myelofibrosis
Other
Blood test
干预措施: Molecular analysis (Other)
Secondary Myelofibrosis
Other
Blood test
干预措施: Molecular analysis (Other)
结局指标
主要结局
Rate of patients with one or more HMR mutations in primary compared to secondary (post PV/ET) MF
时间窗: Baseline
Proportions of patients with HMR mutations in each arm
次要结局
未报告次要终点
研究者
研究点 (1)
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