Lyme Borreliosis and Early Cutaneous 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).

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Key information

Conditions

Erythema Migrans Disease Glossitis Glossitis, Benign Migratory Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Tongue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalo-Universitaire Jean Minjoz, Besançon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, ...)

Treatment and study plan

Skin biopsies

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)

Primary outcomes

Compare the Sensitivity (Percentage of Positive Tests) of the SRM / MS-MS to Techniques of PCR and Culture Borrelia

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).

Percentage of positive tests with all three techniques (SRM/MS-MS ; PCR ; culture)

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: DIABOLYC

Important dates

Study start: 2015
Primary completion: 2024
Study completion: 2024
First posted: Apr 13, 2015
Registry last updated: Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed