Rete Italiana Dei Registri Regionali Delle Sindromi Mielodisplastiche (MDS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 36
- 主要终点
- Prevalence of MDS
研究概览
简要总结
Epidemiological data collection of adult patients affected by myelodysplastic syndrome (MDS) newly diagnosed.
详细描述
Development of an Italian regional registries MDS network using the same electronic case report form for data storage, with the following broad aims:
- Ability to aggregate and process anonymous epidemiological data collected by individual regional registers;
- Ability to aggregate the available data with those of other international registries existing.
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 106 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New diagnosis of MDS
排除标准
- •Patient who refuse the signature of informed consent
结局指标
主要结局
Prevalence of MDS
时间窗: 6 years
Number of cases every 100.000 person
Progression free survival
时间窗: 6 years
Time between MDS diagnosis and relapse/ progression or death due to any causes
Progression to AML
时间窗: 6 years
Time between MDS diagnosis and Progression to AML or death due to any causes
Incidence of MDS diagnosis
时间窗: 6 years
Number of new cases every 100.000 person/year
Overall Response rate
时间窗: 6 years
Proportion of CR or PR after each line of treatment in term of erythroid, platelet and granulocyte response
Overall survival
时间窗: 6 years
Time between MDS diagnosis and death due to any causes
次要结局
未报告次要终点