An observational study in Hairy Cell Leukemia (HCL), sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 3 sites in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-14.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
This is a national multi-centre, experimental, cross-sectional, non-profit study.
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 50 is below the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.
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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.
Inclusion criteria for patients:
Inclusion criteria for Healthy Donors:
Exclusion criteria
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.
Time frame: 1 years
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.
Time frame: 1 years
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IRCCS Azienda Ospedaliero-Universitaria di Bologna