Understanding the Role of Large Extracellular Vesicles in Lymphomas and Lymphoproliferative Disorders: the "Off the Beaten Track" Liquid Biopsy

Completed

• Conditions: Diffuse Large B-Cell Lymphoma; Follicular Lymphoma; Marginal Zone Lymphoma(MZL); Mycosis Fungoides; Chronic Lymphocytic Leukemia; Hairy Cell Leukemia (HCL); T Cell Lymphoma; Multiple Mieloma

• Registration Number: NCT06782854
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

This study aims to investigate the role of extracellular vesicles as diagnosic and prognostic biomarkers in patients with lymphomas or lymphoproliferative disorders. In particular, circulating extracellular vesicles, thanks to their cargo of proteins, lipids, and nucleic acids, play a role in the communication between cells. Since it has been described that these vesicles are able to influence also immune cells, the study of their functions may lead to the discovery of new mechanisms underlying this type of diseases.

Detailed Description

It is a 3-year monocentric in vitro study on human tissue. 50 patients with aggressive and indolent Non-Hodgkin Lymphomas (Diffuse Large B-Cell Lymphoma (DLBCL; Group A; n=10), Follicular Lymphoma (FL; Group B; n=10), Marginal Zone Lymphoma (MZL; Group C; n=10), Peripheral T-Cell Lymphoma (PTCL; Group D; n=10), Mycosis Fungoides (MF; Group E; n=10)), and patients with Chronic Lymphocytic Leukaemia (CLL; N=10; Group F; n=10), Hairy Cell Leukemia (HCL; Group G; n=10), and Multiple Myeloma (MM; N=10; Group H; n=10) will be enrolled over a period of 24 months. Follow-up: 12 months. Patients will be enrolled at the Complex Operative Unit of Haematology-IRCCS Azienda Ospedaliero-Universitaria di Bologna. The peripheral blood samples of patients (40 ml) will be collected only at diagnosis within normal clinical practice, outside of clinical study protocols, and following the treatment guidelines in use at the Centre. The analysis of the samples will be performed at the Unità Operativa Complessa di Ematologia-IRCCS Azienda Ospedaliero-Universitaria di Bologna in collaboration with the Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori' - IRST IRCCS and with the University of Perugia.

Study Timeline

• Study Start: 2022-02-21
• Primary Completion: 2023-02-20
• Study Completion: 2024-11-17
• Status Verified: 2024-12
• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extracellular vesicle characterization	2 years	Comparison of concentration (particles/ml), phenotype, and cargo of extracellular vesicles from patients and healthy donors.
Validation of extracellular vesicles as biomarker	2 years	Correlation of extracellular vesicles' characterization results with biomarkers of disease aggressiveness and short-term response to standard therapy.

Secondary Outcome Measures

Name	Time	Method
Functional effects of extracellular vesicles	2 years	Comparison of functional effects of extracellular vesicles from patients and healthy donors on selected immune cells. The isolated vesicles will be used to treat the immune cells (T cells, B cells, monocytes) to evaluate viability, phenotype, migration ability, and inflammatory cytokine production of the target cells.

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy