Flow Cytometric Immune Monitoring of B. Afzelii-Specific T Lymphocytes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lyme Borreliosis, Lyme Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Characterization of Borrelia afzelii-specific T-cell immune responses by multiparameter flow cytometry [Time frame: At study inclusion (baseline visit)]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpitaux Universitaires de Strasbourg — Strasbourg
Identifiers
NCT: NCT07703787 · PRI 2025 n° HUS 9717