Essential Thrombocythemia (ET), Myelofibrosis (MF), Polycythemia Vera (PV)
Conditions
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.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Validation of extracellular vesicles as biomarker | 1 years | Development of an integrated analysis of clinical data and extracellular vesicle-based scenescence biomarkers to allow the identification of a short-term prognostic index in Myeloproliferative Neoplasm patients. |
Countries
Italy
Outcome results
None listed