Understanding the Role of Large Extracellular Vesicles in Lymphomas and Lymphoproliferative Disorders: the "Off the Beaten Track" Liquid Biopsy
2 other identifiers
observational
102
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 17, 2024
CompletedFirst Submitted
Initial submission to the registry
December 30, 2024
CompletedFirst Posted
Study publicly available on registry
January 20, 2025
CompletedJanuary 20, 2025
December 1, 2024
12 months
December 30, 2024
January 14, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Extracellular vesicle characterization
Comparison of concentration (particles/ml), phenotype, and cargo of extracellular vesicles from patients and healthy donors.
2 years
Validation of extracellular vesicles as biomarker
Correlation of extracellular vesicles' characterization results with biomarkers of disease aggressiveness and short-term response to standard therapy.
2 years
Secondary Outcomes (1)
Functional effects of extracellular vesicles
2 years
Other Outcomes (1)
Extracellular vesicles' cell of origin
1 years
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- \- Concomitant secondary neoplasia.
- Age ≥ 18 years.
- Signed informed consent.
- \- Healthy donors with neoplasia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
Biospecimen
Plasma and mononuclear cells
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lucia Catani, PhD
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2024
First Posted
January 20, 2025
Study Start
February 21, 2022
Primary Completion
February 20, 2023
Study Completion
November 17, 2024
Last Updated
January 20, 2025
Record last verified: 2024-12