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Lyme Borreliosis and Early Cutaneous Diagnostic (DIABOLYC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02414789
Recruitment Status : Recruiting
First Posted : April 13, 2015
Last Update Posted : August 20, 2019
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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).

Condition or disease Intervention/treatment Phase
Erythema Migrans Procedure: Skin biopsies Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Lyme Borreliosis and Early Cutaneous Diagnostic
Actual Study Start Date : August 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: SRM / MS-MS Procedure: 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)

Primary Outcome Measures :
  1. Compare the sensitivity (percentage of positive tests) of the SRM / MS-MS to techniques of PCR and culture Borrelia [ Time Frame: One year study ]
    percentage of positive tests with all three techniques (SRM/MS-MS ; PCR ; culture)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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, ...)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02414789

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Contact: Nathalie BOULANGER, MD +33369551449
Contact: Dan LIPSKER, PhD +33388116197

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Centre Hospitalo-Universitaire Jean Minjoz Active, not recruiting
Besancon, France
Centre Hospitalier William Morey Active, not recruiting
Chalon-sur-Saône, France
Hôpital Pasteur Recruiting
Colmar, France
Contact: Martin MARTINOT, MD   
Hôpital E. Muller Recruiting
Mulhouse, France
Contact: Pierre KIEFFER, MD   
Hôpital Robert Debré Not yet recruiting
Reims, France
Contact: Florent GRANGE, MD   
Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Dan LIPSKER, PhD   
Hôpital Bel Air Recruiting
Thionville, France
Contact: François TRUCHETET, MD   
Sponsors and Collaborators
University Hospital, Strasbourg, France

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Responsible Party: University Hospital, Strasbourg, France Identifier: NCT02414789     History of Changes
Other Study ID Numbers: 6084
First Posted: April 13, 2015    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
erythema migrans
early diagnosis
skin biomarkers
proteomics diagnostic
mass spectrometry
Additional relevant MeSH terms:
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Lyme Disease
Erythema Chronicum Migrans
Glossitis, Benign Migratory
Skin Diseases
Skin Manifestations
Signs and Symptoms
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Skin Diseases, Bacterial
Spirochaetales Infections
Skin Diseases, Infectious
Tongue Diseases
Mouth Diseases
Stomatognathic Diseases