European Registry for Myeloproliferative Neoplasms (MPNs) - Update of ERNEST Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,010
- 试验地点
- 6
- 主要终点
- Number of death
研究概览
简要总结
The Fondazione per la Ricerca Ospedale di Bergamo (FROM) decided to propose and promote the completion of ERNEST registry: the aim of the project is to obtain up-to-date estimates of clinical outcome of these patients in primary and secondary Myelofibrosis that have been included in the 'original' ERNEST study. The last was conducted between 2012 and beginning of 2015 including 1292 patients with Myelofibrosis, but it was interrupted in 2015 because of bankruptcy of the previous sponsor.
详细描述
Follow-up of patients already been registered in the ERNEST registry resulting alive and/or in active surveillance at November 2014 (Blood 2014 124:1849) will be updated retrospectively until December 2020. Data collection will be centralized at Fondazione per la Ricerca Ospedale di Bergamo (FROM), and performed by a web-based and Electronic Data Capture (EDC) system through ad hoc electronic case report forms (e-CRFs). The e-CRFs system will be pre-filled with pre-existing data collected from cases already entered in the registry. Information on therapies received and outcome events occurred (in term of death, evolution to acute leukemia, secondary cancer and cardiovascular complications) until December 2020 will be recorded by authorized participating investigators.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •previous registration in the ERNEST registry (2012 - 2014)
- •diagnosis of MF performed between January 2001 and 2012 December
- •Signed informed consent to continue participation in the registry
排除标准
- 未提供
结局指标
主要结局
Number of death
时间窗: 18 years
Overall Survival
次要结局
- Number of patients with secondary tumor (ST)(18 years)
- Number of patients with evolution to acute leukemia (AL)(18 years)
- Number of patients with cardiovascular (CV) complications(18 years)