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

NCT ID: NCT06764524

Last Updated: 2025-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-05

Study Completion Date

2027-12-04

Brief Summary

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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)

Detailed Description

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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.

Conditions

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Hairy Cell Leukemia (HCL)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* WHO2022-defined diagnosis of Hairy Cell Leukemia.
* age ≥18 years.
* signed informed consent.


* age ≥18 years.
* Volunteers in general good health, free from any disease or serious illness.
* Signed informed consent.

Exclusion Criteria

\- None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lucia Catani, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Lucia Catani, PhD

Role: CONTACT

+390512143837

Facility Contacts

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Lucia Catani, PhD

Role: primary

+390512143837

Other Identifiers

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RC-2024-2790616

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EV-ABLE

Identifier Type: -

Identifier Source: org_study_id

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