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

Active, not recruiting

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

• Registration Number: NCT06798805
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-02-15
• Primary Completion: 2024-08-08
• Status Verified: 2024-12
• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma extracellular vesicle characterization	2 years	Comparison of concentration (particles/mL), phenotype, and cargo between extracellular vesicles from patients and healthy donors.
Validation of extracellular vesicles as biomarker	2 years	Correlation of extracellular vesicles' characterization data with markers of disease aggressiveness.

Secondary Outcome Measures

Name	Time	Method
Cell culture-derived extracellular vesicle characterization	2 years	Comparison of the phenotype of extracellular vesicles derived from the supernatant of selected immune cells cultured in the presence or absence of inflammatory factors.
Extracellular vesicle-mediated senescence	1 years	Comparison of senescence biomarkers (such as p16 and p21) in selected immune cells from healthy donors in the presence or absence of extracellular vesicles from patients or healthy donors.

Trial Locations

Locations (5)

ASST Spedali Civili di Brescia; 🇮🇹 Brescia, BS, Italy

Ospedale S.Maria delle Croci; 🇮🇹 Ravenna, RA, Italy

Arcispedale S. Maria Nuova - IRCCS; 🇮🇹 Reggio Emilia, RE, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori- IRST; 🇮🇹 Meldola, FC, Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy