Healthy DonorMicroLipidsNCT06183632
Lipid Characterisation of Plasma Microparticles in a Large Population of Healthy Donors
An observational study of Healthy Donor, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Extracellular vesicles (EVs) are membrane structures containing numerous mediators categorised according to their size and mode of production. Among them, microparticles (MPs) are EVs between 100 nm and 1 μm in size that are produced by budding at the plasma membrane of different cell types following different… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Donor
- What is being tested?
- blood sampling
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2024to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Eligible patients will be identified by EFS staff at the time of their appointment for a platelet donation at the EFS - Maison du Don, Dijon.
Who may be able to join
- Person who has given his/her non-opposition
- All healthy volunteers are eligible to donate according to EFS criteria.
Who cannot join
- Person subject to a legal protection measure (curatorship, guardianship, etc)
- Pregnant, parturient or breast-feeding women
- Adults who are incapable or unable to give their consent
- Minors
- Person not eligible to donate according to EFS criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Damien LELEU, 0380669248 ext. +33, Damien.leleu@chu-dijon.fr
About this study
Extracellular vesicles (EVs) are membrane structures containing numerous mediators categorised according to their size and mode of production. Among them, microparticles (MPs) are EVs between 100 nm and 1 μm in size that are produced by budding at the plasma membrane of different cell types following different mechanisms of cell activation or death. MPs include a large pool of bioactive molecules, such as lipids, proteins or nucleic acids. This makes them important mediators of intercellular communication, increasingly recognised for their role in various biological processes such as inflammation, coagulation, immune response and tumour progression. Their ability to transmit molecular signals between cells may have implications for disease pathogenesis and cellular interactions in pathological microenvironments. These MPs therefore appear to be an innovative biomarker, potentially useful in the early management of disease, both in terms of diagnosis and as a therapeutic target.
The main techniques used to analyse these MPs include flow cytometry, which enables surface markers to be quantified and determined, and electron microscopy, which provides a direct view of their morphology and structure. Molecular biology, such as the quantitative PCR technique, is also an approach used by several teams, notably to search for RNA or DNA fragments involved in various biological processes. However, few studies have focused on the lipid composition of these MPs. Since MPs are membrane vesicles, they are a major lipid reservoir. In addition, lipids represent a significant population of molecules with extensive properties, whether in inflammation, cell proliferation, energy metabolism, etc.
The aim of this project is to develop a reliable and robust method for analysing plasma MP concentration, phenotype and lipid composition in a population of healthy volunteers. These parameters will subsequently provide a comparator for studying MPs in populations of patients suffering from cardiovascular and/or inflammatory diseases.
- Conditions
- Healthy Donor
- Being tested
- blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
3 x 7mL EDTA blood tubes
| Study group | Role | What they receive |
|---|---|---|
| Healthy donor | All healthy volunteers are eligible to donate according to EFS criteria. Receives: Biological: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
microparticle concentration, phenotyping and lipid composition in a population of healthy subjects.
Measured: Through study completion, an average of 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start25 Jan 2024
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy DonorStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183632
- Sponsor's protocol ID
- LELEU 2023
- Acronym
- MicroLipids
- Status last verified
- Feb 2024
- First submitted
- 14 Dec 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid Characterisation of Plasma Microparticles in a Large Population of Healthy Donors
- ClinicalTrials.gov ID
- NCT06183632
- Acronym / sponsor ID
- MicroLipids / LELEU 2023
- Conditions
- Healthy Donor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 27 Dec 2023 (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.
Extracellular vesicles (EVs) are membrane structures containing numerous mediators categorised according to their size and mode of production. Among them, microparticles (MPs) are EVs between 100 nm and 1 μm in size that are produced by budding at the plasma membrane of different cell types following different mechanisms of cell activation or death. MPs include a large pool of bioactive molecules, such as lipids, proteins or nucleic acids. This makes them important mediators of intercellular communication, increasingly recognised for their role in various biological processes such as inflammation, coagulation, immune response and tumour progression. Their ability to transmit molecular signals between cells may have implications for disease pathogenesis and cellular interactions in pathological microenvironments. These MPs therefore appear to be an innovative biomarker, potentially useful in the early management of disease, both in terms of diagnosis and as a therapeutic target.
The main techniques used to analyse these MPs include flow cytometry, which enables surface markers to be quantified and determined, and electron microscopy, which provides a direct view of their morphology and structure. Molecular biology, such as the quantitative PCR technique, is also an approach used by several teams, notably to search for RNA or DNA fragments involved in various biological processes. However, few studies have focused on the lipid composition of these MPs. Since MPs are membrane vesicles, they are a major lipid reservoir. In addition, lipids represent a significant population of molecules with extensive properties, whether in inflammation, cell proliferation, energy metabolism, etc.
The aim of this project is to develop a reliable and robust method for analysing plasma MP concentration, phenotype and lipid composition in a population of healthy volunteers. These parameters will subsequently provide a comparator for studying MPs in populations of patients suffering from cardiovascular and/or inflammatory diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy donor | – | Biological: blood samplingAll healthy volunteers are eligible to donate according to EFS criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will be identified by EFS staff at the time of their appointment for a platelet donation at the EFS - Maison du Don, Dijon.
Key inclusion criteria (2 listed)
- Person who has given his/her non-opposition
- All healthy volunteers are eligible to donate according to EFS criteria.
Key exclusion criteria (5 listed)
- Person subject to a legal protection measure (curatorship, guardianship, etc)
- Pregnant, parturient or breast-feeding women
- Adults who are incapable or unable to give their consent
- Minors
- Person not eligible to donate according to EFS criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampling3 x 7mL EDTA blood tubes | Biological | Healthy donor |
Primary outcome
microparticle concentration, phenotyping and lipid composition in a population of healthy subjects.
Time frame: Through study completion, an average of 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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.
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 Healthy Donor, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 7 Feb 2024. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damien LELEU (0380669248 ext. +33, Damien.leleu@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microparticle concentration, phenotyping and lipid composition in a population of healthy subjects. (time frame: Through study completion, an average of 60 months). 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 7 Feb 2024.