CClinicalTrials.gg
Status unknownNCT05625100CXCL13-LYMEUpdated Oct 31, 2023

Place of Intrathecal CXCL-13 in the Diagnosis of Lyme Neuroborreliosis

An observational study in Lyme Borreliosis, sponsored by University Hospital, Strasbourg, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-31.

Sponsored by University Hospital, Strasbourg, France · Observational

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
141
Ages
18 Years and older
Sex
All
01

Study summary

Neuroborreliosis (NBL) is diagnosed in 10-15% of patients with Lyme borreliosis. In Europe in adults, the main clinical manifestation is called "Bannwarth syndrome". This includes painful meningoradiculitis, sometimes accompanied by cranial nerve neuritis. Current European guidelines issued by the European Federation of Neurological Societies (EFNS) recommend the following triad for the diagnosis of "definite NBL": (i) Neurological symptoms suggestive of NBL without any other obvious cause; (ii) CSF pleocytosis; (iii) Intrathecal production of specific anti-Borreliella antibodies. CXCL13, C-X-C chemokine motif ligand 13, is a chemokine implicated in B cell chemotaxis. Extensive literature exists on the analysis of CXCL13i as a diagnostic marker for acute NBL. A recent meta-analysis from 2018, published by Rupprecht et al finds an overall sensitivity and specificity of 89% and 96% respectively, indicating satisfactory diagnostic value. In this study, the investigators wish to assess the place of this new marker in the diagnosis of neuroborreliosis before proposing it as a test carried out by the Borrelia CNR.

02

Conditions studied

  • Lyme Borreliosis

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Keywords

  • Lyme borreliosis
  • Lyme neuroborreliosis
  • Bannwarth syndrome
  • Intrathecal CXCL-13
03

In context

Lyme Disease

91 studies on the registry are indexed under Lyme Disease; 27 are open to participants now.

This study's planned enrollment of 141 is below the median of 400 across 39 observational studies indexed under Lyme Disease.

Browse Lyme Disease studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Major subject (≥18 years old) subject having consulted at the HUS between 01/01/2013 and 31/12/2018

Inclusion criteria

  • Major subject (≥18 years old)
  • Subject having consulted at the HUS between 01/01/2013 and 31/12/2018
  • Subject not having, after being informed, expressed their opposition to the reuse of their data for the purposes of this research

Exclusion criteria

Exclusion criteria:

  • Subject who expressed their opposition to participating in the study
  • Subject under guardianship or curatorship
  • Subject under safeguard of justice
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
141 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Positivity of the marker (CXCL13-intrathecal) for known cases of NBL and negativity of this one for known non-NBL cases

    Time frame: Files analysed retrospectively from January 01, 2013 to December 31, 2018 will be examined

07

Study locations

1 of 1 sites recruiting
  • Service Laboratoire de Bactériologie - Plateau Technique de Microbiologie - CHU de Strasbourg - France
    Strasbourg, 67091, France
    • Benoit JAULHAC, MD, PhD · Contact · benoit.jaulhac@chru-strasbourg.fr · 33 3 69 55 14 52
    • Benoit JAULHAC, MD, PhD · Principal investigator
    • Antoine GRILLON, MD · Principal investigator
    • Laure Dolfus, MD · Sub investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05625100
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Nov 22, 2022
Start date
Jul 13, 2020
Primary completion
Dec 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Oct 31, 2023

Study contacts

Benoit JAULHAC, MD, PhD
Contact
benoit.jaulhac@chru-strasbourg.fr
33 3 69 55 14 52

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 status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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