Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Hairy Cell Leukemia (HCL), Marginal Zone Lymphoma(MZL), Multiple Mieloma, Mycosis Fungoides, T Cell Lymphoma
Conditions
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.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Extracellular vesicles' cell of origin | 1 years | Correlation of extracellular vesicles' phenotype with the corresponding cells of origin. |
Countries
Italy
Outcome results
None listed