An interventional study of Skin biopsies in Erythema Migrans, sponsored by University Hospital, Strasbourg, France. Completed at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Diagnostic
Test and evaluate a new diagnostic method (SRM-MS/MS: Selected Reaction Monitoring- Mass spectrometry) for Lyme Borreliosis on human skin biopsies. Patients included are those with the early skin manifestation (erythema migrans).
This new proteomic method will be compared to the two existing method: culture of Borrelia and PCR detection of Borrelia (DNA detection of the bacteria).
25 studies on the registry are indexed under Glossitis, Benign Migratory; 4 are open to participants now.
This study's enrollment of 84 is below the median of 200 across 13 interventional studies indexed under Glossitis, Benign Migratory.
Browse Glossitis, Benign Migratory studies →University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.
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Exclusion Criteria:
Procedure: Skin biopsies
Skin biopsies of patients with Lyme disease (erythema migrans) infected with Borrelia burgdorferi sensu lato will be analyzed by three diagnostic techniques : molecular technique (PCR), biological technique (culture of the bacteria) and proteomics technique (SRM/ MS-MS)
Compare the Sensitivity (Percentage of Positive Tests) of the SRM / MS-MS to Techniques of PCR and Culture Borrelia
Percentage of positive tests with all three techniques (SRM/MS-MS ; PCR ; culture)
Time frame: At inclusion (Day 0), immediately after skin biopsy sampling, with laboratory analysis performed subsequently (culture up to 8 weeks for Borrelia growth, PCR and targeted proteomics after sample processing).
74 participants with erythema migrans planned for inclusion, plus 20 control participants.
| Milestone | Lyme Borreliosis Patients | Negative Control Patients |
|---|---|---|
| Started | 74 | 11 |
| Completed | 46 | 10 |
| Not completed | 28 | 1 |
Percentage of positive tests with all three techniques (SRM/MS-MS ; PCR ; culture)
| Percentage of positive tests (%) | Lyme Borreliosis Patients | Negative Control Patients |
|---|---|---|
| Compare the Sensitivity (Percentage of Positive Tests) of the SRM / MS-MS to Techniques of PCR and Culture Borrelia | 0.61 (0.45 to 0.75) | 0.00 (0.00 to 0.31) |
Collected over All-Cause Mortality, Serious and Other (Not Including Serious) Adverse Events were not monitored / assessed. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lyme Borreliosis Patients | — | — | — |
| Negative Control Patients | — | — | — |
1 control excluded from analysis (absence of egative Lyme serology at the time of biopsy), 7 patients Lyme excluded from analysis (5 biopsies lost due to incubator problem, data lost from 2 patients)
| Age, Continuous(years) | Lyme Borreliosis | Negative Control Patients | Total |
|---|---|---|---|
| Mean | 58 (20 to 82) | 64 (53 to 75) | 59 (20 to 82) |
| Sex: Female, Male(Participants) | Lyme Borreliosis | Negative Control Patients | Total |
|---|---|---|---|
| Female | 43 | 5 | 48 |
| Male | 31 | 6 | 37 |
| Race and Ethnicity Not Collected(Participants) | Lyme Borreliosis | Negative Control Patients | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Strasbourg, France →