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Not yet recruitingNCT07898826REFLEXUpdated Oct 27, 2026

Functional Regulation of Autoreactive Lymphocytes: Phenotypic and Transcriptomic Investigations in Healthy Subjects

An interventional study of Blood sampling at D0 and Blood sampling at D0, M12 and M24 in Healthy Subjects, sponsored by University Hospital, Brest. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by University Hospital, Brest · Not applicable, Interventional, and Basic science

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
18 Years to 69 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Healthy Subjects
03

In context

Lead sponsor

University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.

Browse University Hospital, Brest studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Other
    Transversal cohort

    1 blood sampling at Day 0

    Diagnostic Test: Blood sampling at D0

  • Other
    Longitudinal cohort

    1 blood sampling at Day 0, M12 and M24

    Diagnostic Test: Blood sampling at D0, M12 and M24

Interventions

  • Diagnostic testBlood sampling at D0

    Blood sampling (56mL)

  • Diagnostic testBlood sampling at D0, M12 and M24

    Blood sampling (56mL)

06

What researchers measure

Primary outcomes

  1. 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 (%).

    Time frame: 1 day

Secondary outcomes

  1. Detailed phenotyping of B-cell subpopulations

    Time frame: 1 day

  2. Transcriptomic results for a selected subset of the cohort (10%)

    Time frame: 1 day

  3. Results of functional analyses for a selected subset of the cohort (10%)

    Time frame: 1 Day

  4. 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

    Time frame: From 1 day to 24 months

07

Study locations

1 site
  • Centre Hospitalier Universitaire de Brest
    Brest, 29200, France
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Nov 2029, 36 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2026
First posted
Oct 27, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Nov 1, 2029
CompletionEst.
Nov 1, 2031
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07898826
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Oct 27, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Nov 1, 2029 (estimated)
Completion
Nov 1, 2031 (estimated)
Last update
Oct 27, 2026

Study contacts

Eléonore Bettacchioli
Contact
eleonore.bettacchioli@chu-brest.fr
+332 30 33 84 37

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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