Lyme Borreliosis and Early Cutaneous Diagnostic

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-06

Study Completion Date

2024-02-01

Brief Summary

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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).

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Detailed Description

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Conditions

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Erythema Migrans

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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SRM / MS-MS

Group Type EXPERIMENTAL

Skin biopsies

Intervention Type PROCEDURE

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)

Interventions

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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)

Intervention Type PROCEDURE

Eligibility Criteria

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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, ...)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No