Understanding how extracellular vesicles affect Hairy Cell Leukemia
Decoding the Extracellular Vesicles-driven Communication in the Microenvironment of Hairy Cell Leukemia to Improve Patient Care Management
This study is trying to see how tiny particles in the blood affect Hairy Cell Leukemia and whether they help the cancer survive and avoid the immune system, involving both patients with the disease and healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 3 sites (Palermo, PA and 2 other locations) |
| Trial ID | NCT06774677 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the role of extracellular vesicles in the microenvironment of Hairy Cell Leukemia (HCL). By analyzing these small particles found in plasma, the study seeks to uncover how they contribute to tumor maintenance and immune evasion. The research will involve multiple centers across the nation and will focus on identifying a specific signature related to disease outcomes based on the characteristics of these vesicles. Participants will include both patients diagnosed with HCL and healthy volunteers.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of Hairy Cell Leukemia.
Not a fit: Patients who do not have Hairy Cell Leukemia or are under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient care management and targeted therapies for Hairy Cell Leukemia.
How similar studies have performed: While the specific approach of this study is novel, similar studies investigating extracellular vesicles in other cancers have shown promising results.
Eligibility criteria
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 this trial is running
Palermo, PA and 2 other locations
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello — Palermo, PA, Italy (Recruiting)
- Policlinico Santa Maria alla Scotte — Siena, Si, Italy (Recruiting)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.