Clinical trial NCT06782854: Understanding the Role of Large Extracellular Vesicles in Lymphomas and Lymphoproliferative Disorders: the "Off the Beaten Track" Liquid Biopsy
Official 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
Study type: OBSERVATIONAL
Overall status: 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
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at diagnosis (Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Peripheral T-Cell Lymphoma, Mycosis Fungoides, Chronic Lymphocytic Leukemia, Hairy Cell Leukemia, Multiple Myeloma) will be enrolled over a 24 month period. Follow-up 1 year.

Sex/age matched healthy donors will be recruited for peripheral blood collection among volunteers of a no profit organization called Bologna AIL.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Extracellular vesicle characterization
timeFrame: 2 years
measure: Validation of extracellular vesicles as biomarker
timeFrame: 2 years
Secondary outcomes:
measure: Functional effects of extracellular vesicles
timeFrame: 2 years
Other outcomes:
measure: Extracellular vesicles' cell of origin
timeFrame: 1 years
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Lucia Catani, PhD
role: PRINCIPAL_INVESTIGATOR
References: