Flow Cytometric Immune Monitoring of B. Afzelii-Specific T Lymphocytes (NCT07703787) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Flow Cytometric Immune Monitoring of B. Afzelii-Specific T Lymphocytes
France20 participantsStarted 2026-09
Plain-language summary
Lyme borreliosis diagnosis currently relies on clinical assessment and detection of Borrelia-specific antibodies. However, serology does not allow reliable assessment of active infection. Evaluation of the cellular immune response through Borrelia-specific T lymphocyte monitoring may provide complementary diagnostic and prognostic information.
This study aims to assess Borrelia afzelii-specific T-cell responses using multiparameter flow cytometry after stimulation with standardized peptide pools. This approach enables the characterization of CD4+ and CD8+ T cells, including polyfunctional immune responses.
The diagnostic and prognostic value of this immunomonitoring strategy will be evaluated in patients with acrodermatitis chronica atrophicans, a late manifestation of Lyme borreliosis associated with B. afzelii.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Subject informed of the results of the prior medical examination
* Subject informed about the objectives, procedures, and potential risks of the study
* Subject affiliated with a health insurance/social security scheme (beneficiary or dependent)
* Subject having provided dated and signed informed consent
* Lyme borreliosis/acrordermatitis chronica atrophicans (ACA) group:
Subject presenting clinical and biological criteria or Borrelia identification confirming chronic atrophic acrodermatitis, with appropriate antibiotic treatment initiated less than 18 months ago or untreated
• Control group: Healthy subject with no history of Lyme disease and negative Lyme serology
Exclusion Criteria:
* Body weight \< 50 kg
* Pregnancy or breastfeeding
* Diabetes mellitus
* Immunodeficiency or ongoing immunosuppressive treatment (including oral corticosteroids)
* Contraindication to local anesthesia with lidocaine, with or without adrenaline
* Inability to provide informed consent (emergency situation, inability to understand study information, …)
* Participation in another clinical trial
* Legal protection measures (guardianship, curatorship, or legal safeguard)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Characterization of Borrelia afzelii-specific T-cell immune responses by multiparameter flow cytometry