Evaluation of New Biomarkers of Thrombosis in Myeloproliferative Neoplasms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 397
- 试验地点
- 24
- 主要终点
- Correlation between NET biomarkers and the risk of thrombosis
研究概览
简要总结
Thrombosis is the main cause of morbidity and mortality in patients with myeloproliferative neoplasms (MPN). However, the pathogenesis of thrombosis in MPN is still largely elusive. Neutrophils can release their decondensed chromatin as a network of extracellular fibers named NET for "neutrophils extracellular trap". NETs are known to be procoagulant. Our main objective is to quantify NETs biomarkers expression in MPN patients and define if they could be used as prognostic factors in the outcome of thrombosis in these patients.
详细描述
Myeloproliferative neoplasms (MPN) are acquired clonal hematopoietic stem cell disorders, characterized by an increase in one or more myeloid lineages. The Philadelphia chromosome negative (Ph-) MPN include polycythemia vera (PV) with an excess of red blood cells, essential thrombocythemia (ET) with an increase in platelets and primary myelofibrosis (PMF). Arterial and venous thromboses are the main causes of morbidity and mortality in MPN with reported incidences ranging from 12-39% in PV and 11-25% in ET. The pathogenesis of thrombosis in MPN patients is complex and still largely elusive. The overproduction of neutrophils could be an important risk factor in the thrombus formation. Indeed neutrophils are known to promote thrombosis when they release their decondensed chromatin as a network of extracellular fibers named NET for "neutrophils extracellular trap". Increased NETosis has been reported in a mouse model of MPN. The main objective of this study is to investigate whether NET biomarkers are associated with increased thrombotic risk in patients with ET. Indeed, an international thrombotic prognostic score has been published in ET, ie the IPSET Thrombosis score (history of thrombosis, age, presence of JAK2V617F, cardiovascular risk factors).
Plasma from MPN patients will be collected, at the time of diagnosis, and measure markers of neutrophil activation, including NET biomarkers. The IPSET Thrombosis score will be evaluated in patients with ET and the correlation between the IPSET Thrombosis score and these biomarkers will be measured.
No follow-up is required for this study.
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
- •Adults (age ≥18 years),
- •Patients diagnosed with Polycythemia vera (PV) or essential thrombocythemia (ET) according to WHO 2008 criteria,
- •Affiliated to the national social security system,
- •Signed informed consent form will be required for each included subject after having read the information note,
- •Patient agreeing to be included in the FIMBANK register and having signed the corresponding consent
排除标准
- •Adults (age >18 years), male or female,
- •Patients treated with heparin or undergoing cytoreductive treatment,
- •Pregnant or lactating woman,
- •Person under guardianship, tutorship or other legal protection scheme or incapable of giving consent
结局指标
主要结局
Correlation between NET biomarkers and the risk of thrombosis
时间窗: 1 day
Correlation between NET biomarkers measurated in plasma samples and the risk of thrombosis evaluated by the prognostic score IPSET thrombosis
次要结局
- Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and a history of thrombosis(1 day)
- Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and the presence of JAK2V617F mutation(1 day)
- Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and the subtype of MPN disease (ET or PV)(1 day)