Clinical trial NCT06798805: Unraveling the Role of Extracellular Vesicles-driven Senescence in Myeloproliferative Neoplasms
Official title: Unraveling the Role of Extracellular Vesicles-driven Senescence in Myeloproliferative Neoplasms
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Essential Thrombocythemia (ET)
Myelofibrosis (MF)
Polycythemia Vera (PV)
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Plasma extracellular vesicle characterization
timeFrame: 2 years
measure: Validation of extracellular vesicles as biomarker
timeFrame: 2 years
Secondary outcomes:
measure: Cell culture-derived extracellular vesicle characterization
timeFrame: 2 years
measure: Extracellular vesicle-mediated senescence
timeFrame: 1 years
Other outcomes:
measure: Validation of extracellular vesicles as biomarker
timeFrame: 1 years
Locations:
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia
state: BS
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori- IRST
state: FC
city: Ravenna
country: Italy
facility: Ospedale S.Maria delle Croci
state: RA
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova - IRCCS
state: RE
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Lucia Catani, MD
role: PRINCIPAL_INVESTIGATOR
References: