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Completed

NCT Number: NCT06782854

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for patients:

  • Age ≥ 18 years.
  • Patients with WHO 2017-defined diagnosis of indolent and aggressive Non-Hodgkin Lymphoma (specifically Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Peripheral T-Cell Lymphoma, Mycosis Fungoides) or Chronic Lymphocytic Leukemia or Hairy Cell Leukemia or Multiple Myeloma.
  • Signed informed consent.

Exclusion criteria

for patients:

  • Concomitant secondary neoplasia.

Inclusion criteria

for healthy donors:

  • Age ≥ 18 years.
  • Signed informed consent.

Exclusion criteria

for healthy donors:

  • Healthy donors with neoplasia.

Treatment and study plan

Primary outcomes

  1. Extracellular vesicle characterization

    Time frame: 2 years

    Comparison of concentration (particles/ml), phenotype, and cargo of extracellular vesicles from patients and healthy donors.

  2. Validation of extracellular vesicles as biomarker

    Time frame: 2 years

    Correlation of extracellular vesicles' characterization results with biomarkers of disease aggressiveness and short-term response to standard therapy.

Secondary outcomes

  1. Functional effects of extracellular vesicles

    Time frame: 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.

Other outcomes

  1. Extracellular vesicles' cell of origin

    Time frame: 1 years

    Correlation of extracellular vesicles' phenotype with the corresponding cells of origin.

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Understanding the Role of Large Extracellular Vesicles in Lymphomas and Lymphoproliferative Disorders: the "Off the Beaten Track" Liquid Biopsy - A Prospective Monocentric in Vitro Study on Human Tissues

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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