About this trial
This is a national multi-centre, experimental, cross-sectional, non-profit study.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
WHO2022-defined diagnosis of Hairy Cell Leukemia.
Age ≥18 years.
Signed informed consent.
Age ≥18 years.
Disqualifiers
None
Trial population
The study population will be composed by Hairy Cell Leukemia patients subdivided as newly diagnosed (n=10), relapsed meeting treatment indications (N=5) and in complete response \>2 years (N=10) and by Healthy Donors (n=25), enrolled among volunteers through the non-profit organization AIL Bologna ODV.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Extracellular vesicle characterization
Verify whether hairy cell leukemia patients at different status (at diagnosis, in complete remission \> 2 years, or relapsed meeting treatment indications) display specific extracellular vesicle-based signatures.
Secondary outcomes
Functional effects of extracellular vesicles
Elucidate whether plasma-derived extracellular vesicles of hairy cell leukemia patients and healthy donors and in vitro hairy cell-derived extracellular vesicles may functionally educate the immune microenvironment. Elucidate whether plasma-derived extracellular vesicles of patients and healthy donors may functionally affect the isolated hairy cells. Understand whether plasma-derived extracellular vesicles of patients and healthy donors and in vitro hairy cell-derived extracellular vesicles might shape the stromal microenvironment toward fibrosis.
Sponsors and contacts
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