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Flow Cytometric Immune Monitoring of B. Afzelii-Specific T Lymphocytes

Key facts

Who runs it
University Hospital, Strasbourg, France
Where
France1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
20 people, planned
Started
Sept 2026
Expected to end
Mar 2029
Type of study
Observational, 2 groups
Record updated
14 July 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

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Who can take part

  • 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

Who cannot take part

  • Immunodeficiency or ongoing immunosuppressive treatment (including oral corticosteroids)
  • Diabetes mellitus
  • Body weight < 50 kg
  • Pregnancy or breastfeeding
  • 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)

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

  • Lyme borreliosis / Acrodermatitis chronica atrophicans (ACA) group
  • Control group

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
14 July 2026