Lyme Borreliosis and Early Cutaneous Diagnostic (DIABOLYC)
Primary Purpose
Erythema Migrans
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Skin biopsies
Sponsored by
About this trial
This is an interventional diagnostic trial for Erythema Migrans focused on measuring erythema migrans, Lyme, early diagnosis, skin biomarkers, proteomics diagnostic, mass spectrometry
Eligibility Criteria
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, ...)
Sites / Locations
- Centre Hospitalo-Universitaire Jean Minjoz
- Centre Hospitalier William Morey
- Hôpital Pasteur
- Hôpital E. Muller
- Hôpital Robert Debré
- Hôpitaux Universitaires de Strasbourg
- Hôpital Bel Air
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SRM / MS-MS
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT02414789
First Posted
April 8, 2015
Last Updated
August 18, 2023
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT02414789
Brief Title
Lyme Borreliosis and Early Cutaneous Diagnostic
Acronym
DIABOLYC
Official Title
Lyme Borreliosis and Early Cutaneous Diagnostic
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2015 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema Migrans
Keywords
erythema migrans, Lyme, early diagnosis, skin biomarkers, proteomics diagnostic, mass spectrometry
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SRM / MS-MS
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Skin biopsies
Intervention Description
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 Outcome Measure Information:
Title
Compare the sensitivity (percentage of positive tests) of the SRM / MS-MS to techniques of PCR and culture Borrelia
Description
percentage of positive tests with all three techniques (SRM/MS-MS ; PCR ; culture)
Time Frame
One year study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, ...)
Facility Information:
Facility Name
Centre Hospitalo-Universitaire Jean Minjoz
City
Besancon
Country
France
Facility Name
Centre Hospitalier William Morey
City
Chalon-sur-Saône
Country
France
Facility Name
Hôpital Pasteur
City
Colmar
Country
France
Facility Name
Hôpital E. Muller
City
Mulhouse
Country
France
Facility Name
Hôpital Robert Debré
City
Reims
Country
France
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Hôpital Bel Air
City
Thionville
Country
France
12. IPD Sharing Statement
Learn more about this trial
Lyme Borreliosis and Early Cutaneous Diagnostic
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