Healthy SubjectsREFLEXNCT07898826
Functional Regulation of Autoreactive Lymphocytes: Phenotypic and Transcriptomic Investigations in Healthy Subjects
A study testing Blood sampling at D0 and Blood sampling at D0, M12 and M24 in people with Healthy Subjects, run by University Hospital, Brest at 1 site in France.
Trial summary
The goal of this study is to study the autoreactive lymphocytes in healthy volunteers. More specifically, this research aims to identify what distinguishes the autoreactive lymphocytes found in healthy individuals from those observed in patients, and to understand the mechanisms that prevent the onset of autoimmune… Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Blood sampling at D0 and Blood sampling at D0, M12 and M24
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2026to 1 Nov 2031
- Phase
- Interventional
- 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 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged between 18 ans 69
- Weight > 50kg
- Able to give free and informed consent
- Patient from the local area (livingin the region where the recruitment centre is located)
- Non-inclusion Criteria:
- History of cancer within the last 5 years
Show all 20Show fewer
- Autoimmune or chronic inflammatory disease
- Current infection (acute or chronic)
- Severe asthma
- Recent heavy bleeding
- Anticoagulant therapy, coagulation disorder, anaemia, cardiovascular disease (valvular heart disease, arrhythmias, arterial vascular insufficiency)
- Pregnancy and the postpartum period (6 months; self-reported on questionnaires)
- Poor tolerance to blood donation (whether or not related to haemodynamic instability)
- History of seizures or epilepsy
- History of stroke, transient ischaemic attack or repeated episodes of syncope
- Immunosuppressive treatment (current oral or injectable corticosteroids, CYC, MTX/LEF, AZA/MMF, anti-CD20, etc.)
- Persons deprived of their liberty
- Persons receiving psychiatric care
- Persons admitted to a health or social care facility
- Adults subject to a legal protection order
Who cannot join
None listed.
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
Centre Hospitalier Universitaire de Brest
Brest, 29200
Mathilde Guillo, +33 2 30 33 84 73, mathilde.guillo@chu-brest.fr
About this study
The goal of this study is to study the autoreactive lymphocytes in healthy volunteers. More specifically, this research aims to identify what distinguishes the autoreactive lymphocytes found in healthy individuals from those observed in patients, and to understand the mechanisms that prevent the onset of autoimmune disease in healthy individuals.
Participants will have a single visit where they will undergo a blood drawing (56mL). Some participants will be proposed to join a longitudinal cohort consisting in two supplementary visits at M12 and M24 where they will undergo a new blood drawing (56mL).
Read the detailed description
The visit will involve data collection and a blood sample (56 mL). The following analyses will be carried out where possible:
- Comprehensive phenotyping of lymphocyte subpopulations (100% of the cohort)
- Phenotyping of antigen-recognising sorted subpopulations (10% of the cohort)
- Cell sorting for RNA-seq (10% of the cohort)
- Cell sorting for functional study (10% of the cohort)
Additional analyses on a subsample of the cohort will prioritise subjects with the highest frequencies of autoreactive cells.
The longitudinal follow-up will enable us to determine whether or not auto-reactive cells persist, and to assess fluctuations in lymphocyte subpopulations present in healthy subjects.
- Conditions
- Healthy Subjects
- Being tested
- Blood sampling at D0, Blood sampling at D0, M12 and M24
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling at D0Diagnostic test
Blood sampling (56mL)
Blood sampling at D0, M12 and M24Diagnostic test
Blood sampling (56mL)
| Study group | Role | What they receive |
|---|---|---|
| Transversal cohort | Other | 1 blood sampling at Day 0 Receives: Diagnostic Test: Blood sampling at D0 |
| Longitudinal cohort | Other | 1 blood sampling at Day 0, M12 and M24 Receives: Diagnostic Test: Blood sampling at D0, M12 and M24 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The identification of auto-reactive cells in healthy subjects in response to the auto-antigens tested
This criterion will be assessed by the frequency of auto-reactive B lymphocytes identified (%).
Measured: 1 day
Secondary outcomes (4)
Detailed phenotyping of B-cell subpopulations
Measured: 1 day
Transcriptomic results for a selected subset of the cohort (10%)
Measured: 1 day
Results of functional analyses for a selected subset of the cohort (10%)
Measured: 1 Day
Establishment of a longitudinal biological sample collection
Biocollection comprising 300 patients after 3 years, 20% of whom will be followed up annually for 2 years
Measured: From 1 day to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The included subjects will be divided into two sub-cohorts: * A transversal sub-cohort with subjects followed for 1 day (a single sample collection at Day 0). * A longitudinal sub-cohort with subjects followed for 24 months (sample collections at Day 0, Month 12 and Month 24). The choice of the cohort will be based on the subject's preference, whilst ensuring that no more than 20 per cent of patients are included in the longitudinal cohort.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898826
- Sponsor's protocol ID
- 29BRC25.0395
- Other IDs
- 2026-A01291-50
- Acronym
- REFLEX
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 27 Oct 2026
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Regulation of Autoreactive Lymphocytes: Phenotypic and Transcriptomic Investigations in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07898826
- Acronym / sponsor ID
- REFLEX / 29BRC25.0395
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Nov 2031 (estimated)
- First posted
- 27 Oct 2026 (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.
The goal of this study is to study the autoreactive lymphocytes in healthy volunteers. More specifically, this research aims to identify what distinguishes the autoreactive lymphocytes found in healthy individuals from those observed in patients, and to understand the mechanisms that prevent the onset of autoimmune disease in healthy individuals.
Participants will have a single visit where they will undergo a blood drawing (56mL). Some participants will be proposed to join a longitudinal cohort consisting in two supplementary visits at M12 and M24 where they will undergo a new blood drawing (56mL).
Detailed description
The visit will involve data collection and a blood sample (56 mL). The following analyses will be carried out where possible:
- Comprehensive phenotyping of lymphocyte subpopulations (100% of the cohort)
- Phenotyping of antigen-recognising sorted subpopulations (10% of the cohort)
- Cell sorting for RNA-seq (10% of the cohort)
- Cell sorting for functional study (10% of the cohort)
Additional analyses on a subsample of the cohort will prioritise subjects with the highest frequencies of autoreactive cells.
The longitudinal follow-up will enable us to determine whether or not auto-reactive cells persist, and to assess fluctuations in lymphocyte subpopulations present in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The included subjects will be divided into two sub-cohorts: * A transversal sub-cohort with subjects followed for 1 day (a single sample collection at Day 0). * A longitudinal sub-cohort with subjects followed for 24 months (sample collections at Day 0, Month 12 and Month 24). The choice of the cohort will be based on the subject's preference, whilst ensuring that no more than 20 per cent of patients are included in the longitudinal cohort.
| Arm | Type | Receives |
|---|---|---|
| Transversal cohort | Other | Diagnostic Test: Blood sampling at D01 blood sampling at Day 0 |
| Longitudinal cohort | Other | Diagnostic Test: Blood sampling at D0, M12 and M241 blood sampling at Day 0, M12 and M24 |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Adults aged between 18 ans 69
- Weight > 50kg
- Able to give free and informed consent
- Patient from the local area (livingin the region where the recruitment centre is located)
- History of cancer within the last 5 years
Key exclusion criteria (0 listed)
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 sampling at D0Blood sampling (56mL) | Diagnostic test | Transversal cohort |
| Blood sampling at D0, M12 and M24Blood sampling (56mL) | Diagnostic test | Longitudinal cohort |
Primary outcome
The identification of auto-reactive cells in healthy subjects in response to the auto-antigens tested
Time frame: 1 day
This criterion will be assessed by the frequency of auto-reactive B lymphocytes identified (%).
4 secondary outcomes
Detailed phenotyping of B-cell subpopulations
Time frame: 1 day
Transcriptomic results for a selected subset of the cohort (10%)
Time frame: 1 day
Results of functional analyses for a selected subset of the cohort (10%)
Time frame: 1 Day
Establishment of a longitudinal biological sample collection
Time frame: From 1 day to 24 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 27 Oct 2026.
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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?
A study testing Blood sampling at D0 and Blood sampling at D0, M12 and M24 in people with Healthy Subjects, run by University Hospital, Brest 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 20 inclusion and 0 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: opening soon, as of the sponsor's last update on 27 Oct 2026. 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 Eléonore Bettacchioli (+332 30 33 84 37, eleonore.bettacchioli@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The identification of auto-reactive cells in healthy subjects in response to the auto-antigens tested (time frame: 1 day). 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 27 Oct 2026.