Decoding the Extracellular Vesicles-driven Communication in the Microenvironment of Hairy Cell Leukemia to Improve Patient Care Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hairy Cell Leukemia (HCL). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This is a national multi-centre, experimental, cross-sectional, non-profit study.
Detailed description
Extracellular vesicles are small particles circulating in plasma and documented as key players of intercellular crosstalk thanks to their cargo of proteins, lipids, and nucleic acids. The driving hypothesis of this study is that in Hairy Cell Leukemia-derived extracellular vesicles contribute to the maintenance of the tumor clone through regulation of selected key cells of the tumor microenvironment including immune cells and stromal cells, likely favoring immune evasion and marrow fibrosis. As a consequence, these circulating particles may be instrumental at identifying a biology-related, disease-specific and extracellular vesicle-based signature associated to outcomes.
Primary outcome measures
- Extracellular vesicle characterization [Time frame: 1 years]
Secondary outcome measures (1)
- Functional effects of extracellular vesicles [Time frame: 1 years]
Eligibility criteria
Inclusion criteria for patients:
- WHO2022-defined diagnosis of Hairy Cell Leukemia.
- Age ≥18 years.
- Signed informed consent.
Inclusion criteria for Healthy Donors:
- Age ≥18 years.
- Volunteers in general good health, free from any disease or serious illness.
- Signed informed consent.
Exclusion criteria
\- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Italy · 3 centers
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello — Palermo
- Policlinico Santa Maria alla Scotte — Siena
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06774677 · HCL-EV · PNRR-TR1-2023-12377450