Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06798805

Unraveling the Role of Extracellular Vesicles-driven Senescence in Myeloproliferative Neoplasms

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Plasma extracellular vesicle characterization

    Time frame: 2 years

    Comparison of concentration (particles/mL), phenotype, and cargo between extracellular vesicles from patients and healthy donors.

  2. Validation of extracellular vesicles as biomarker

    Time frame: 2 years

    Correlation of extracellular vesicles' characterization data with markers of disease aggressiveness.

Secondary outcomes

  1. Cell culture-derived extracellular vesicle characterization

    Time frame: 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.

  2. Extracellular vesicle-mediated senescence

    Time frame: 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 outcomes

  1. Validation of extracellular vesicles as biomarker

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jan 29, 2025
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.