Clinical trial Recruiting at 1 site Observational Ages 18 and up

Investigating extracellular vesicles in patients with Hairy Cell Leukemia

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

Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06764524 · Data updated 2026-11-12

This study is testing if tiny particles in the blood of people with Hairy Cell Leukemia can help us understand the disease better and find new ways to track its progress.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Academic / other
Locations1 site (Bologna)
StatusRecruiting
StartedDecember 5, 2024
Main results expectedJune 5, 2027
Study endsDecember 4, 2027
Registry record updatedJanuary 8, 2025
Trial IDNCT06764524 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older with a WHO2022-defined diagnosis of Hairy Cell Leukemia.

Probably not a fit

Patients who are not diagnosed with Hairy Cell Leukemia or those under 18 years old may not receive any benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to analyze extracellular vesicles (EV) in patients with Hairy Cell Leukemia (HCL) at various stages, including diagnosis, complete remission for over two years, and relapse requiring therapy. By examining the composition of these vesicles, the study seeks to uncover potential biomarkers related to the disease and its biology. The research will involve collecting plasma samples from patients and healthy donors to compare the EV signatures and understand their role in the tumor microenvironment.

Why it matters

Potential benefit: If successful, this study could lead to the identification of new biomarkers that improve patient care management for those with Hairy Cell Leukemia.

How similar studies have gone: While the specific approach of analyzing EV in HCL is novel, similar studies in other cancers have shown promise in identifying biomarkers.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Bologna, Italy
    Recruiting

Study contacts

  • Principal investigator: Lucia Catani, PhD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • Study coordinator: Lucia Catani, PhD
  • Email: lucia.catani@unibo.it
  • Phone: +390512143837

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.