Decoding the Extracellular Vesicles-driven Communication in the Microenvironment of Hairy Cell Leukemia to Improve Patient Care Management

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

This is a national multi-centre, experimental, cross-sectional, non-profit study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

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