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

NCT06798805 | Active Not Recruiting

• 2 other identifiers: EVs-SeneFIN-RER_BU_2020_29
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 5

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.

Conditions

Essential Thrombocythemia (ET); Myelofibrosis (MF); Polycythemia Vera (PV)

Outcome Measures

Primary Outcomes (2)

• Plasma extracellular vesicle characterization

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

  2 years

• Validation of extracellular vesicles as biomarker

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

  2 years

Secondary Outcomes (2)

• Cell culture-derived extracellular vesicle characterization

  2 years

• Extracellular vesicle-mediated senescence

  1 years

Other Outcomes (1)

• Validation of extracellular vesicles as biomarker

  1 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• age ≥ 18 years.
• patients with WHO2017-defined diagnosis of Myeloproliferative Neoplasms.
• patients at first diagnosis.
• Informed consent signed.

You may not qualify if:

• \- patients with concomitant second neoplasia
• age ≥ 18 years.
• Informed consent signed.
• \- Healthy Donors with neoplasia.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (5)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

ASST Spedali Civili di Brescia

Brescia, BS, 25123, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori- IRST

Meldola, FC, 47014, Italy

Location

Ospedale S.Maria delle Croci

Ravenna, RA, 48100, Italy

Location

Arcispedale S. Maria Nuova - IRCCS

Reggio Emilia, RE, 42123, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and mononuclear cells

MeSH Terms

Conditions

Thrombocythemia, Essential; Primary Myelofibrosis; Polycythemia Vera

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombocytosis; Blood Platelet Disorders; Myeloproliferative Disorders; Bone Marrow Diseases; Hemorrhagic Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Lucia Catani, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 29, 2025
• Study Start: February 15, 2022
• Primary Completion: August 8, 2024
• Study Completion: August 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2024-12

Locations

IT (5)