Role of Monocytes Sub-populations in Thrombosis Associated With Myeloproliferative Neoplasms (MonSThr)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 5
- 主要终点
- History of thrombosis
研究概览
简要总结
Myeloproliferative neoplasms (MPN) are hematological malignancies associated with a major risk of thrombosis. Monocytes are hematopoietic cells with a central role in thrombosis. An activation of monocytes has been demonstrated in MPN patients. However, their study in MPN and their thrombotic complications has never been performed. In this study, we aim to evaluate the association between monocytes sub-populations and thrombotic risk in MPN patients.
详细描述
Myeloproliferative Neoplasms (MPN) are hematological malignancies characterized by an increased risk of thrombosis, in particular in Polycythemia Vera (PV) and Essential Thrombocythemia (ET). Predicting the risk of thrombosis in PV and ET patients helps at determining their care (use of antiaggregant and cytoreductive therapies), but relies only on limited clinical and biological criteria (age over 60 years, history of thrombosis, presence of the JAK2V617F mutation, presence of cardiovascular risk factors). Monocytes sub-populations could represent a new biomarker of thrombotic risk in PV and ET patients. Indeed, it has been shown that monocytes are activated and exhibit pro-thrombotic properties in MPN patients, especially those with a history of thrombosis. Some studies have suggested the CD16+ monocytes (intermediate and non-classical monocytes) are associated with an increased risk of arterial thrombosis. Because these monocytes are observed in inflammatory contexts, and because MPN are associated with a chronic inflammation, MPN could be associated with an increase of the proportion or the absolute count of CD16+ monocytes that could be involved in thrombotic complications observed in PV and ET patients.
In this project, an association between the proportion of CD16+ monocytes and thrombosis in PV and ET patients will be searched. Monocytes sub-populations will be studied in PV and ET patients at diagnosis as described by Selimoglu-Buet et al.1 The proportion of CD16+ (intermediate + non-classical) monocytes will be compared between patients presenting with a history of thrombosis and those without any history of thrombosis. The association between the absolute count and the proportion of CD16+, intermediate and non-classical monocytes and the occurrence of thrombosis before diagnosis, the MPN phenotype, the driver mutation, the allelic burden, the clinico-biological presentation and the existence of an inflammatory state will also be evaluated. Due to the low frequency and the high latency of thrombosis reoccurrence, patients' samples only at diagnosis (or during the year after diagnosis) will be analyzed and an association with a history of thrombosis will be made.
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 patients (age ≥ 18 years)
- •Inclusion at diagnosis or during the year following the diagnosis of PV or ET (2016 WHO criteria except bone marrow biopsy that is optional in the presence of a marker of clonality)
- •Subject registered with a social security scheme
- •Written informed consent obtained
排除标准
- •Patients with cytoreductive treatment (hydroxyurea, anagrelide, interferon, ruxolitinib) at the time of blood sampling
- •Chronic inflammatory disease (cancer, vasculitis, rheumatism, hepato-gastro-intestinal diseases).
- •Long term anti-inflammatory treatments:
- •Corticoids
- •Nonsteroidal anti-inflammatory drugs
- •Aspirin (> 325 mg per day)
- •Cyclo-oxygenase II inhibitors
- •Persons under judicial safeguards, trustee or curatorship
- •Person unable to give her consent
- •Non-cooperative person
- •Exclusion period after another clinical study or participation to another clinical study in the 30 days before inclusion
研究组 & 干预措施
PV and ET patients
For the main objective, the cohort will be composed of PV and ET patients, some with a history of thrombosis and some without any history of thrombosis. A comparison will also be performed between patients with different MPN (PV or ET) and different driver mutation (JAK2V617F, JAK2 exon 12, CALR, MPL or absence of such mutations)
干预措施: 1 additional tube of blood (Biological)
结局指标
主要结局
History of thrombosis
时间窗: At inclusion, up to 1 year after diagnosis
Patients wil be classified as having a history of thrombosis if they had a deep vein thrombosis, pulmonary embolism, splanchnic thombosis or any other significant thrombosis. Tinnitus, vertigo, headaches, erythromelalgia as well as superficial vein thrombosis will not be considered as thrombotic events
次要结局
- Hemoglobin level(At inclusion, up to 1 year after diagnosis)
- Driver mutation of MPN(At inclusion, up to 1 year after diagnosis)
- Count of monocytes sub-populations(At inclusion, up to 1 year after diagnosis)
- Proportion of CD16+ monocytes in PV and ET patients(At inclusion, up to 1 year after diagnosis)
- Type of MPN(At inclusion, up to 1 year after diagnosis)
- Leukocytes level(At inclusion, up to 1 year after diagnosis)
- Thrombosis risk factors(At inclusion, up to 1 year after diagnosis)
- Proportion of monocytes sub-populations(At inclusion, up to 1 year after diagnosis)
- Platelets level(At inclusion, up to 1 year after diagnosis)