IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
NCT Number: NCT06782854
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Bologna, 40138, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for patients:
Exclusion criteria
for patients:
Inclusion criteria
for healthy donors:
Exclusion criteria
for healthy donors:
Time frame: 2 years
Comparison of concentration (particles/ml), phenotype, and cargo of extracellular vesicles from patients and healthy donors.
Time frame: 2 years
Correlation of extracellular vesicles' characterization results with biomarkers of disease aggressiveness and short-term response to standard therapy.
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.
Time frame: 1 years
Correlation of extracellular vesicles' phenotype with the corresponding cells of origin.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT03833180
Acute Lymphoid Leukemia, Acute Myeloid Leukemia
Duarte, California, United States
View Trial DetailsNCT02652715
Adult Nasal Type Extranodal NK/T-cell Lymphoma, Adult T-Cell Leukemia/Lymphoma
Rochester, Minnesota, United States
View Trial DetailsNCT03501576
Chronic Disease, Chronic Lymphocytic Leukemia
Atlanta, Georgia, United States
View Trial DetailsNCT03884998
Chronic Disease, Chronic Lymphocytic Leukemia
Duarte, California, United States
View Trial Details