NCT06764524

Brief Summary

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)

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
19mo left

Started Dec 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

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 Progress47%
Dec 2024Dec 2027

Study Start

First participant enrolled

December 5, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 2, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2027

Last Updated

January 8, 2025

Status Verified

December 1, 2024

Enrollment Period

2.5 years

First QC Date

January 2, 2025

Last Update Submit

January 2, 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 of immune failure.

    2 years

Secondary Outcomes (1)

  • Extracellular vesicles' functions and biomarker validation

    2 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 (3 groups: patients at diagnosis (n=10); patients in complete response for \>2 years (n=10); relapsed patients meeting treatment indications (n=5)) and by Healthy Donors (n=25) enrolled among volunteers of the no profit organization BolognAIL.

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 (1)

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 2, 2025

First Posted

January 8, 2025

Study Start

December 5, 2024

Primary Completion (Estimated)

June 5, 2027

Study Completion (Estimated)

December 4, 2027

Last Updated

January 8, 2025

Record last verified: 2024-12

Locations

IT(1)