NCT02192619招募中不适用
National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2014年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- diagnostic quality indicators
研究概览
简要总结
The registry aims to document epidemiologic data, treatment and long-term outcome as well as quality of life of patients with APL. Additionally, a biobanking project for further translational studies is integrated.
Prospective population-based non-interventional and non-randomized multicenter registry.
详细描述
- collection of epidemiological data for APL: age distribution, prognostic factors, distribution of subgroups, incidence
- documentation of efficacy and safety of the first line and salvage therapy in APL including
- documentation of minimal residual disease (MRD)
- correlation of clinical outcomes with chosen therapy
- collection and evaluation of quality of life
- validation of published prognostic factors / new potential prognostic factors
- acquisition of bone marrow, peripheral blood and buccal swab samples for biobanking and translational studies under the umbrella of the specific study-group biobanking concepts
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •newly-diagnosed APL (either de novo or therapy-related), within 12 months of diagnosis
- •or relapsed APL, within 12 months of diagnosis of relapse
- •confirmed by the presence of the translocation t(15; 17)
- •and / or confirmed by the detection of the fusion transcript of PML/RARa
排除标准
- 未提供
结局指标
主要结局
diagnostic quality indicators
时间窗: yearly follow up for 5 years
epidemiological parameters
时间窗: yearly follow up for 5 years
response, recurrence and time of death and resulting outcomes RFS and OS
时间窗: yearly follow up for 5 years
type of therapy
时间窗: yearly follow up for 5 years
次要结局
- grade IV toxicities(yearly follow up for 5 years)
- complete remission (CR) and CRm(yearly follow up for 5 years)
- treatment related mortality (TRM)(yearly follow up for 5 years)
- cumulative incidence of relapse (CIR)(yearly follow up for 5 years)
- quality of life (QoL): EORTC QLQ-C30(yearly follow up for 5 years)
研究者
研究点 (1)
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