Unraveling the Role of Extracellular Vesicles-driven Senescence in Myeloproliferative Neoplasms
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 110
- 试验地点
- 5
- 主要终点
- Plasma extracellular vesicle characterization
研究概览
简要总结
In this study the aim is to investigate the pathogenetic role of extracellular vesicles and senescence in Myeloproliferative Neoplasms. In particular, the goal of this project is to identify possible EV-based biomarkers of senescence according to gender, which are disease-specific, biology-related, and predictive of short-term outcome in terms of Event-Free Survival and to define personalized targets for new therapeutic approaches.
详细描述
This is a 3-year multi-centre prospective in vitro study. 120 patients with MPN (ET (n=45), PV (n=45), and MF (n=30)) will be enrolled for a period of 22 months. Follow-up: 12 months. Patients (ET=Group A; PV=Group B; MF=Group C) will be enrolled at the Complex Operative Unit of Haematology-IRCCS Azienda Ospedaliero-Universitaria di Bologna and at the Haematology Centres of Reggio Emilia, Brescia, Meldola, and Ravenna. Peripheral blood samples from patients with ET, PV, and MF (Group A-C; 40 ml) and/or bone marrow samples from patients with ET and PV (Group A, B; 5 ml) will be collected at diagnosis as part of normal clinical practice. The samples will be analysed at the Complex Operative Unit of Haematology-IRCCS Azienda Ospedaliero-Universitaria di Bologna in collaboration with the Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori' - IRST IRCCS (analysis of EV size and concentration) and with the University of Perugia (analysis of EV lipid cargo). The data analysis will be carried out in collaboration with the Department of Physics and Astronomy of the University of Bologna.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Plasma extracellular vesicle characterization
时间窗: 2 years
Comparison of concentration (particles/mL), phenotype, and cargo between extracellular vesicles from patients and healthy donors.
Validation of extracellular vesicles as biomarker
时间窗: 2 years
Correlation of extracellular vesicles' characterization data with markers of disease aggressiveness.
次要结局
- Cell culture-derived extracellular vesicle characterization(2 years)
- Extracellular vesicle-mediated senescence(1 years)
