An observational study in Essential Thrombocythemia (ET), Myelofibrosis (MF) and Polycythemia Vera (PV), sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Active, not recruiting at 5 sites in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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.
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.
195 studies on the registry are indexed under Thrombocythemia, Essential; 45 are open to participants now.
This study's enrollment of 110 is below the median of 206 across 38 observational studies indexed under Thrombocythemia, Essential.
Browse Thrombocythemia, Essential studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 509 studies on the registry; 285 are open to participants now.
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Patients with Myeloproliferative Neoplasms (Essential Thrombocythemia, Polycythemia Vera, Myelofibrosis) will be enrolled over a 28 months period. Follow-up 1 year.
As a control, sex/age matched Healthy Donors will be enrolled among volunteers of a no profit organization called AIL Bologna.
Inclusion criteria for patients:
Exclusion criteria for patients:
- patients with concomitant second neoplasia
Inclusion criteria for Healthy Donors:
Exclusion criteria for Healthy Donors:
- Healthy Donors with neoplasia.
Plasma extracellular vesicle characterization
Comparison of concentration (particles/mL), phenotype, and cargo between extracellular vesicles from patients and healthy donors.
Time frame: 2 years
Validation of extracellular vesicles as biomarker
Correlation of extracellular vesicles' characterization data with markers of disease aggressiveness.
Time frame: 2 years
Cell culture-derived extracellular vesicle characterization
Comparison of the phenotype of extracellular vesicles derived from the supernatant of selected immune cells cultured in the presence or absence of inflammatory factors.
Time frame: 2 years
Extracellular vesicle-mediated senescence
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.
Time frame: 1 years
Validation of extracellular vesicles as biomarker
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.
Time frame: 1 years
This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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