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Trial record 23 of 64 for:    lyme

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.
ClinicalTrials.gov Identifier: NCT02414789
Recruitment Status : Recruiting
First Posted : April 13, 2015
Last Update Posted : September 8, 2017
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment
Erythema Migrans Procedure: Skin biopsies

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Arms and Interventions

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)

Outcome Measures

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)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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, ...)
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02414789

Contact: Nathalie BOULANGER, MD +33369551449 nathalie.boulanger@chru-strasbourg.fr
Contact: Dan LIPSKER, PhD +33388116197 dan.lipsker@chru-strasbourg.fr

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       martin.martinot@ch-colmar.fr   
Hôpital E. Muller Recruiting
Mulhouse, France
Contact: Pierre KIEFFER, MD       kiefferp@ch-mulhouse.fr   
Hôpital Robert Debré Not yet recruiting
Reims, France
Contact: Florent GRANGE, MD       fgrange@chu-reims.fr   
Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Dan LIPSKER, PhD       dan.lipsker@chru-strasbourg.fr   
Hôpital Bel Air Recruiting
Thionville, France
Contact: François TRUCHETET, MD       f.truchetet@chr-metz-thionville.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02414789     History of Changes
Other Study ID Numbers: 6084
First Posted: April 13, 2015    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017

Keywords provided by University Hospital, Strasbourg, France:
erythema migrans
early diagnosis
skin biomarkers
proteomics diagnostic
mass spectrometry

Additional relevant MeSH terms:
Lyme Disease
Erythema Chronicum Migrans
Glossitis, Benign Migratory
Skin Diseases
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