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NCT Number: NCT06774677

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, PA, Italy

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About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Extracellular vesicle characterization

    Time frame: 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 outcomes

  1. Functional effects of extracellular vesicles

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lucia Catani, PhD

CONTACT

[email protected]

+390512143837

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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