跳至主要内容
临床试验/NCT06798805
NCT06798805进行中(未招募)不适用

Unraveling the Role of Extracellular Vesicles-driven Senescence in Myeloproliferative Neoplasms

IRCCS Azienda Ospedaliero-Universitaria di Bologna5 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年2月15日最近更新:

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

Loading locations...

相似试验

Unraveling the Role of Extracellular Vesicles-driven... | 临床试验