NCT06774677

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Dec 2024

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Dec 2024Aug 2026

Study Start

First participant enrolled

December 12, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2026

Expected
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

January 14, 2025

Status Verified

December 1, 2024

Enrollment Period

1.7 years

First QC Date

January 9, 2025

Last Update Submit

January 9, 2025

Conditions

Hairy Cell Leukemia (HCL)

Outcome Measures

Primary Outcomes (1)

  • Extracellular vesicle characterization

    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.

    1 years

Secondary Outcomes (1)

  • Functional effects of extracellular vesicles

    1 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be composed by Hairy Cell Leukemia patients subdivided as newly diagnosed (n=10), relapsed meeting treatment indications (N=5) and in complete response \>2 years (N=10) and by Healthy Donors (n=25), enrolled among volunteers through the non-profit organization AIL Bologna ODV.

You may qualify if:

  • 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.

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

Palermo, PA, 90121, Italy

RECRUITING

Policlinico Santa Maria alla Scotte

Siena, SI, 53100, Italy

RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and mononuclear cells

MeSH Terms

Conditions

Leukemia, Hairy Cell

Condition Hierarchy (Ancestors)

LeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Lucia Catani, PhD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucia Catani, PhD

CONTACT

+390512143837lucia.catani@unibo.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2025

First Posted

January 14, 2025

Study Start

December 12, 2024

Primary Completion (Estimated)

August 11, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

January 14, 2025

Record last verified: 2024-12

Locations

IT(3)