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Borrelia Species in Cutaneous Lyme Borreliosis

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: NCT00576082
Recruitment Status : Recruiting
First Posted : December 18, 2007
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Société de Dermatologie Française
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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Brief Summary:
The aim of this study is to identify the species of Borrelia involved in the dermatologic manifestations of Lyme borreliosis in France. Indeed, in Europe, as opposed to North America, many bacterial species are involved in Lyme borreliosis. Yet, very few is known about the prevalence and distribution of different bacteriological species that account for the disease in France. Thus, this a nation-wide study in which all French dermatologists are invited to participate. Every adult patient presenting with one of the cutaneous manifestation of Lyme borreliosis: erythema migrans, lymphocytoma or acrodermatitis chronica atrophicans can be included in the study. If the patient agrees participating, after information and written consent, a cutaneous biopsy will be performed in order to isolate Borrelia by means of culture and PCR. An estimated 400 biopsies should be performed within 2 years.

Condition or disease Intervention/treatment
Lyme Borreliosis Other: Cutaneous biopsy

Study Design
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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: DIVERSITY OF BORRELIA SPECIES INVOLVED IN CUTANEOUS MANIFESTATIONS OF LYME BORRELIOSIS IN FRANCE
Actual Study Start Date : March 2008
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Lyme Disease

Groups and Cohorts
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Intervention Details:
  • Other: Cutaneous biopsy
    Cutaneous biopsy in order to search Borrelia by means of culture and PCR in this tissue sample

Outcome Measures
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Biospecimen Retention:   Samples With DNA
Cutaneous biopsy specimen

Eligibility Criteria
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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
Sampling Method:   Probability Sample
Study Population
Every adult patient presenting with either erythema migrans, borrelial lymphocytoma or acrodermatitis chronica atrophicans
Criteria

Inclusion criteria:

  • Informed adult patient who signed written consent with one the following conditions:
  • erythema migrans
  • borrelial lymphocytoma
  • acrodermatitis chronica atrophicans

Exclusion criteria:

  • pregnancy or lactation
  • allergy to local anesthesia
  • patient who refuses biopsy
Contacts and Locations
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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): NCT00576082


Contacts
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Contact: Dan LIPSKER, MD 33.3.88.11.61.79 dan.lipsker@chru-strasbourg.fr

Locations
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France
Service de Dermatologie, Hôpital Civil Recruiting
Strasbourg, France, 67091
Contact: Dan LIPSKER, MD    33.3.88.11.61.79    dan.lipsker@chru-strasbourg.fr   
Contact: Benoît JAULHAC, MD    33.3.90.24.37.80    benoit.jaulhac@medecine.u-strasbg.fr   
Principal Investigator: Dan LIPSKER, MD         
Sub-Investigator: Benoît JAULHAC, MD         
Sub-Investigator: Bernard CRIBIER, MD         
Sub-Investigator: Carine KIEFFER, MD         
Sub-Investigator: Eric FROUIN, MD         
Sub-Investigator: Pauline LEMORDANT, MD         
Sub-Investigator: Cécile PERRIGOUARD, MD         
Sub-Investigator: Jean-Nicolas SCRIVENER, MD         
Sub-Investigator: Virginie LUTZ, MD         
Service des Maladies infectieuses et tropicales, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Yves HANSMANN, MD    33.3.69.55.09.78    yves.hansmann@chru-strasbourg.fr   
Sub-Investigator: Yves HANSMANN, MD         
Sub-Investigator: Guillaume CAMUSET, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Société de Dermatologie Française
Investigators
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Principal Investigator: Dan LISPKER, MD Hôpitaux Universitaires de Strasbourg
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00576082    
Other Study ID Numbers: 3977
First Posted: December 18, 2007    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Keywords provided by University Hospital, Strasbourg, France:
Lyme borreliosis
Erythema migrans
Borrelial lymphocytoma
Acrodermatitis chronica atrophicans
 Borrelia burgdorferi
Borrelia afzelii
Borrelia garinii
Additional relevant MeSH terms:
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Borrelia Infections
Lyme Disease
Gram-Negative Bacterial Infections
 Bacterial Infections
Spirochaetales Infections
Tick-Borne Diseases