Erythema Migrans
Conditions
Keywords
erythema migrans, Lyme, early diagnosis, skin biomarkers, proteomics diagnostic, mass spectrometry
Brief summary
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).
Interventions
PROCEDURESkin 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)
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Erythema migrant as criteria EUCALB or atypical form associated to tick's sting * Patient having signed a consent * Patient affiliated to a social security scheme
Exclusion criteria
* Prior treatment with antibiotics * Erythema migrans on the face * Bleeding disorders * Anticoagulant treatment * Inability to give clear information (subject in an emergency situation, understanding of the topic difficulty, ...)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the Sensitivity (Percentage of Positive Tests) of the SRM / MS-MS to Techniques of PCR and Culture Borrelia | 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). | Percentage of positive tests with all three techniques (SRM/MS-MS ; PCR ; culture) |
Countries
France
Participant flow
Recruitment details
74 participants with erythema migrans planned for inclusion, plus 20 control participants.
Pre-assignment details
Participants with suspected erythema migrans were screened for eligibility and included after informed consent signature. Two skin biopsies were collected from each enrolled participant for Borrelia detection by culture, PCR, and proteomics. Control participants were recruited in the digestive surgery department and included only if Lyme serology was negative.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 59 years |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed