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NCT Number: NCT06764524

Hairy Cell Leukemia: Harnessing the Full Power of Extracellular Vesicles to Improve Patient Care Management

Check whether patients with Hairy Cell Leukemia (HCL) of different status (at diagnosis, in complete remission > 2 years or relapsed requiring therapy) have a 'signature' of altered immunity based on extracellular vesicles (EV)

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Key information

Conditions

Hairy Cell Leukemia (HCL) Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Hairy Cell Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Lucia Catani, PhD

CONTACT

[email protected]

+390512143837

About this study

Extracellular vesicles are small particles detected within plasma and recognized as mediators of intercellular communication thanks to their cargo of proteins, lipids, and nucleic acids. However, the composition of vesicles from Hairy Cell Leukemia patients, which may hold the key to unraveling their involvement and function within tumor microenvironment, is totally unknown. The aim of this study is to characterize these extracellular vesicles in order to identify biology-related and disease-specific biomarkers.

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: 2 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 of immune failure.

Secondary outcomes

  1. Extracellular vesicles' functions and biomarker validation

    Time frame: 2 years

    Elucidate whether immune cells of hairy cell leukemia patients and of healthy donors show specific phenotype. Elucidate whether plasma-derived extracellular vesicles of hairy cell leukemia patients and of healthy donors affect the cross-talk between hairy cells and immune cells. Confirm the biomarkers identified by using bone marrow biopsy of hairy cell leukemia patients, at diagnosis or relapsed meeting treatment indications.

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
2027
Study completion
2027
First posted
Jan 8, 2025
Registry last updated
Jan 8, 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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