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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Active, not recruiting

Conditions: Myelofibrosis (MF); Polycythemia Vera (PV); Essential Thrombocythemia (ET)

Study type: Observational

Funder types: Other

Identifiers

NCT06798805

FIN-RER_BU_2020_29 (Other Grant/Funding Number)

EVs-Sene

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for patients:

• age ≥ 18 years.
• patients with WHO2017-defined diagnosis of Myeloproliferative Neoplasms.
• patients at first diagnosis.
• Informed consent signed.

Exclusion criteria for patients:

• patients with concomitant second neoplasia

Inclusion criteria for Healthy Donors:

• age ≥ 18 years.
• Informed consent signed.

Exclusion criteria for Healthy Donors:

• Healthy Donors with neoplasia.