Lyme Borreliosis and Early Cutaneous Diagnostic
DIABOLYC
1 other identifier
interventional
84
1 country
7
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2015
CompletedFirst Posted
Study publicly available on registry
April 13, 2015
CompletedStudy Start
First participant enrolled
August 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedOctober 1, 2025
September 1, 2025
8.5 years
April 8, 2015
September 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
One year study
Study Arms (1)
SRM / MS-MS
EXPERIMENTALInterventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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, ...)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Centre Hospitalo-Universitaire Jean Minjoz
Besançon, France
Centre Hospitalier William Morey
Chalon-sur-Saône, France
Hôpital Pasteur
Colmar, France
Hôpital E. Muller
Mulhouse, France
Hôpital Robert Debré
Reims, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
Hôpital Bel Air
Thionville, France
Related Publications (1)
Cantero P, Ehret-Sabatier L, Lenormand C, Hansmann Y, Sauleau E, Zilliox L, Westermann B, Jaulhac B, Mutter D, Barthel C, Perdu-Alloy P, Martinot M, Lipsker D, Boulanger N. Detection of Borrelia burgdorferi sensu lato by proteomics: a complementary diagnosis tool on erythema migrans biopsies. Clin Microbiol Infect. 2025 Jan;31(1):78-86. doi: 10.1016/j.cmi.2024.10.014. Epub 2024 Oct 23.
PMID: 39454756BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2015
First Posted
April 13, 2015
Study Start
August 6, 2015
Primary Completion
February 1, 2024
Study Completion
February 1, 2024
Last Updated
October 1, 2025
Record last verified: 2025-09