NCT05553873招募中不适用
Evaluation of Inflammatory Markers in ph Negative Myeloproliferative Neoplasms: Impact on Outcome and Response to Therapy. Multicenter Retro-prospective Observational Study. The INFLA-ME (INFLAmmation in Myeloproliferative Disease) Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 11
- 主要终点
- CBC with leukocyte formula and calculation of the NLR and PLR ratio
研究概览
简要总结
This study aims to observe inflammatory biomarkers and their trend over the history of the disease in patients suffering from MPN Ph negative; it also wants to identify any correlations between the aforementioned biomarkers and disease outcomes, considering first of all the occurrence of thrombo-haemorrhagic events and the evolution in the accelerated / blast phase of the disease, shedding light on new tools that can potentially guarantee a prompt and better risk stratification
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at the time of diagnosis of MPN Ph negative
- •Diagnosis of PV, ET, PMF or post PV and post ET MF, according to current WHO or IWG-MRT criteria (diagnosis since 2000)
- •Obtaining informed consent
排除标准
- •Life expectancy of less than 6 months
- •Accelerated phase myelofibrosis or MPN with signs of leukemic evolution
结局指标
主要结局
CBC with leukocyte formula and calculation of the NLR and PLR ratio
时间窗: 60 months
Occurrence of arterial and venous thrombotic events
时间窗: 60 months
type of event, time to event after diagnosis, during illness
次要结局
- Time to thrombo-haemorrhagic events(60 months)
- Measurement of new and conventional inflammatory biomarkers(60 months)
- Time to evolution of the PH negative MPN disease into the fibrotic, accelerated or leukemic phase(60 months)
- Time to death and been alive at the end of the study(60 months)
研究者
研究点 (11)
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