Analysis of Risk in MDS Over Time - Comparison of Treated vs Untreated Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9,179
- 试验地点
- 1
- 主要终点
- 1.Overall Survival
研究概览
简要总结
A comparison of treated vs untreated patients with MDS with a sample size of approximately 8000 patients in 11 countries.
详细描述
Non-interventional multicentre retrospective study using chart reviews - study was submitted to the ethics committee of city of Vienna - due to the design of the study no specific approval necessary.
Inclusion of MDS (all subtypes and risk groups) patients according to WHO or oligoblastic AML (RAEB-T according to FAB), untreated and treated during their chronic MDS phase
The 26 centers of the IWG-PM have provided control data set of untreated, all centers will be asked for contribution of treated patients Data will be collected in Austria, Brazil, Czech Republic, France, Germany, Italy, Japan, Netherlands, Spain, UK, USA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MDS (all subtypes and risk groups) according to WHO or oligoblastic AML (RAEB-T according to FAB) patients untreated and treated during their chronic MDS phase
排除标准
- 未提供
结局指标
主要结局
1.Overall Survival
时间窗: From date of diagnosis until the date of death or lost to follow-up, whichever came first. No administrative censoring will be applied to the retrospectively collected data, a minimum period of two months of stable disease will be required.
In \*overall survival\* two possible events are defined: * \*death\* (regarded as complete observation) * \*end of follow up\* (regarded as censored observation) Time is calculated from diagnosis to the first occurrence of one of the above listed events.
2.Time to transformation
时间窗: From date of diagnosis until the date of transformation,death or lost to follow-up, whichever came first. No administrative censoring will be applied to the retrospectively collected data,a minimum period of two months of stable disease will be required.
In \*time to transformation\* three possible events are defined: * \*transformation into AML\* (regarded as complete observation) * \*death without transformation\* (regarded as censored observation) * \*end of follow up\* (regarded as censored observation) Time is calculated from diagnosis to the first occurrence of one of the above listed events. In case of \*transformation into AML\* this results in a complete observation, in case of \*death without transformation\* or \*end of follow up\* the observation is treated as censored.
次要结局
未报告次要终点
研究者
Michael Pfeilstöcker
Univ.Prof.Dr.med.univ.
Mein Hanusch-Krankenhaus