Diffuse Large B-Cell LymphomaNCT06782854
Understanding the Role of Large Extracellular Vesicles in Lymphomas and Lymphoproliferative Disorders: the "Off the Beaten Track" Liquid Biopsy
An observational study of Diffuse Large B-Cell Lymphoma and Follicular Lymphoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma(MZL)
- How many people
- 102 participants
- Where
- 1 siteItaly
- Study dates
- 21 Feb 2022to 17 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
- Age ≥ 18 years.
- Signed informed consent.
Who cannot join
- Concomitant secondary neoplasia.
- Healthy donors with neoplasia.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma(MZL), Mycosis Fungoides, Chronic Lymphocytic Leukemia, Hairy Cell Leukemia (HCL)
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Mycosis Fungoides, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Hairy Cell, Lymphoma, T-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Extracellular vesicle characterization
Comparison of concentration (particles/ml), phenotype, and cargo of extracellular vesicles from patients and healthy donors.
Measured: 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.
Measured: 2 years
Secondary outcomes (1)
Functional effects of extracellular vesicles
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start21 Feb 2022
- Primary completion20 Feb 2023
- Study completion17 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucia Catani, PhD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782854
- Sponsor's protocol ID
- EVs-Lympho
- Other IDs
- RC-2024-2790168
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06782854
- Acronym / sponsor ID
- EVs-Lympho
- Conditions
- Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma(MZL), Mycosis Fungoides, Chronic Lymphocytic Leukemia, Hairy Cell Leukemia (HCL)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 17 Nov 2024 (actual)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
- Age ≥ 18 years.
- Signed informed consent.
Key exclusion criteria (2 listed)
- Concomitant secondary neoplasia.
- Healthy donors with neoplasia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Extracellular vesicle characterization
Time frame: 2 years
Comparison of concentration (particles/ml), phenotype, and cargo of extracellular vesicles from patients and healthy donors.
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.
1 secondary outcome
Functional effects of extracellular vesicles
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucia Catani, PhD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B-Cell Lymphoma and Follicular Lymphoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extracellular vesicle characterization (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.