Austrian Myeloid Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 16
- 主要终点
- To assess the treatment patterns (therapeutic landscape) of patients with myeloid diseases.
研究概览
简要总结
The Austrian Myeloid Registry (aMYELOIDr) is a non-interventional study. It collects data from patients with the myeloid diseases, primarily myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML).The aMYELOIDr is multi-center database collecting data at various sites in Austria and potentially also at other centers in other countries in future. The registry has an electronic case report form (eCRF), where all data is entered by clinical trial personnel and/or physicians. It is set up to collect real-world experience in the management of patients with these diseases in Austria.
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
- •Age >17 years
- •Diagnosis of myeloid disease according to WHO 2016
- •Signed patient informed consent (IC)
排除标准
- •Patient is unable or unwilling to sign IC
结局指标
主要结局
To assess the treatment patterns (therapeutic landscape) of patients with myeloid diseases.
时间窗: Through study completion, median expected within 100 months
Due to the non-interventional nature of the aMYELOIDr, treatment indication, the decision to offer treatment, treatment choice, dose, schedule and dose reductions/escalations shall be exclusively based on the risk/benefit estimation of the treating physician. We recommend compliance current guidelines.
次要结局
- Impact of number and choice of treatment lines on OS as of initial diagnosis and/or as of treatment start(Through study completion, median expected within 100 months)
- Treatment characteristics(Through study completion, median expected within 100 months)
- Overall response rate (ORR)(Through study completion, median expected within 100 months)
- AML transformation(Through study completion, median expected within 100 months)
- Quality of life assessment EQ-5D-5L (optional)(Through study completion, median expected within 100 months)
- Concomitant treatments best supportive care (BSC)(Through study completion, median expected within 100 months)
- Impact of front-line treatment on overall survival (OS)(Through study completion, median expected within 100 months)
- Event free survival (EFS)(Through study completion, median expected within 100 months)
- Treatment safety(Through study completion, median expected within 100 months)
- Concomitant treatments(Through study completion, median expected within 100 months)
- EORTC Quality of life assessment QLQ-C30 (optional)(Through study completion, median expected within 100 months)