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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unraveling the Role of Extracellular Vesicles-driven Senescence in Myeloproliferative Neoplasms
- ClinicalTrials.gov ID
- NCT06798805
- Acronym / sponsor ID
- EVs-Sene
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- Aug 2025 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- age ≥ 18 years.
- patients with WHO2017-defined diagnosis of Myeloproliferative Neoplasms.
- patients at first diagnosis.
- Informed consent signed.
- age ≥ 18 years.
Key exclusion criteria (2 listed)
- patients with concomitant second neoplasia
- Healthy Donors with neoplasia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma extracellular vesicle characterization
Time frame: 2 years
Comparison of concentration (particles/mL), phenotype, and cargo between extracellular vesicles from patients and healthy donors.
Validation of extracellular vesicles as biomarker
Time frame: 2 years
Correlation of extracellular vesicles' characterization data with markers of disease aggressiveness.
2 secondary outcomes
Cell culture-derived extracellular vesicle characterization
Time frame: 2 years
Extracellular vesicle-mediated senescence
Time frame: 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucia Catani, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Thrombocythemia (ET) and Myelofibrosis (MF), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma extracellular vesicle characterization (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.