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Immune cell tracking could sharpen lyme disease diagnosis

NCT ID NCT07703787

Knowledge-focused Sponsor: University Hospital, Strasbourg, France Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study explores a new way to diagnose Lyme disease by measuring immune cell responses to the bacteria. Researchers use a technique called flow cytometry to analyze T-cells from patients with a late-stage form of Lyme disease. The goal is to see if this method can tell active infection apart from past exposure better than standard antibody tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this approach could provide a more reliable way to diagnose active Lyme infection and predict disease progression.
What could go wrong
This is a small, early-stage observational study. The method may not prove accurate enough for clinical use, and results may not apply to all Lyme disease patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

A total of 20 adult participants will be enrolled, including 10 patients with late Lyme borreliosis presenting with acrodermatitis chronica atrophicans (ACA) associated with Borrelia afzelii and 10 healthy adult controls without a history of Lyme disease and with negative Lyme serology.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

acrodermatitis chronica atrophicans Lyme disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lyme borreliosis Lyme disease

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, France

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