NCT03188874招募中不适用
Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15,000
- 试验地点
- 111
- 主要终点
- Epidemiological parameters
研究概览
简要总结
This is a registry study in adult patients with newly diagnosed or refractory/relapsed acute myeloid leukemia.
Investigator's sites: 60 sites in Germany.
Primary objectives:
- Identification of epidemiological data on AML: age, prognostic factors and subgroup distributions. Incidence and age distribution are compared with the data of population-related tumor registry.
- Evaluation of the most important patient-relevant clinical endpoints (outcomes): relapse-free survival (RFS) / time to relapse (TTR), calculation of cumulative incidence of relapse (CIR) and overall survival (OS)
- Documentation of treatment strategy
详细描述
see brief summary
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
- •AML according to the WHO (World Health Organization) diagnostic criteria, including acute promyelocytic leukemia
- •Age ≥ 18 years. There is no upper age limit.
- •Signed written informed consent
排除标准
- •there are no exclusion criteria
结局指标
主要结局
Epidemiological parameters
时间窗: 10 years
Epidemiological parameters
Relapse free survival (RFS)
时间窗: 10 years
Relapse free survival
Overall Survival (OS)
时间窗: 10 years
Overall Survival (OS)
cumulative incidence of relapse (CIR)
时间窗: 10 years
cumulative incidence of relapse (CIR)
Time to relapse (TTR),
时间窗: 10 years
Time to relapse (TTR),
次要结局
- Treatment related mortality (TRM)(yearly follow up 10 years)
- Recording and describing new forms of therapy and new supportive measures(10 years)
- Validation of published prognostic factors at the registry cohort and the search for new possible prognostic factors(10 years)
- Complete Remission (CR)(yearly follow up 10 years)
- Recording and evaluating the quality of therapy and diagnosis(10 years)
- Therapy-associated morbidity(yearly follow up 10 years)
研究者
研究点 (111)
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