Essential Thrombocythemia (ET)NCT06798805
Unraveling the Role of Extracellular Vesicles-driven Senescence in Myeloproliferative Neoplasms
An observational study of Essential Thrombocythemia (ET) and Myelofibrosis (MF), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 5 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Essential Thrombocythemia (ET), Myelofibrosis (MF), Polycythemia Vera (PV)
- How many people
- 110 participants
- Where
- 5 sitesItaly
- Study dates
- 15 Feb 2022to Aug 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- age ≥ 18 years.
- patients with WHO2017-defined diagnosis of Myeloproliferative Neoplasms.
- patients at first diagnosis.
- Informed consent signed.
- age ≥ 18 years.
- Informed consent signed.
Who cannot join
- patients with concomitant second neoplasia
- Healthy Donors with neoplasia.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
ASST Spedali Civili di Brescia
Brescia, BS, 25123
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori- IRST
Meldola, FC, 47014
Ospedale S.Maria delle Croci
Ravenna, RA, 48100
Arcispedale S. Maria Nuova - IRCCS
Reggio Emilia, RE, 42123
About this study
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.
Read the 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.
- Medical subject headings
- Thrombocythemia, Essential, Primary Myelofibrosis, Polycythemia Vera
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma extracellular vesicle characterization
Comparison of concentration (particles/mL), phenotype, and cargo between extracellular vesicles from patients and healthy donors.
Measured: 2 years
Validation of extracellular vesicles as biomarker
Correlation of extracellular vesicles' characterization data with markers of disease aggressiveness.
Measured: 2 years
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start15 Feb 2022
- Primary completion8 Aug 2024
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential Thrombocythemia (ET)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucia Catani, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798805
- Sponsor's protocol ID
- EVs-Sene
- Other IDs
- FIN-RER_BU_2020_29
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No