Hairy Cell Leukemia (HCL)
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extracellular vesicle characterization | 1 years | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional effects of extracellular vesicles | 1 years | 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. |
Countries
Italy
Contacts
Primary ContactLucia Catani, PhD
Outcome results
None listed