Borrelia Species in Cutaneous Lyme Borreliosis
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| ClinicalTrials.gov Identifier: NCT00576082 |
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Recruitment Status :
Recruiting
First Posted : December 18, 2007
Last Update Posted : April 17, 2019
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Sponsor:
University Hospital, Strasbourg, France
Collaborator:
Société de Dermatologie Française
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
| Tracking Information | |||||
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| First Submitted Date | December 17, 2007 | ||||
| First Posted Date | December 18, 2007 | ||||
| Last Update Posted Date | April 17, 2019 | ||||
| Actual Study Start Date | March 2008 | ||||
| Estimated Primary Completion Date | April 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures | Not Provided | ||||
| Original Primary Outcome Measures | Not Provided | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Borrelia Species in Cutaneous Lyme Borreliosis | ||||
| Official Title | DIVERSITY OF BORRELIA SPECIES INVOLVED IN CUTANEOUS MANIFESTATIONS OF LYME BORRELIOSIS IN FRANCE | ||||
| 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Cutaneous biopsy specimen
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| Sampling Method | Probability Sample | ||||
| Study Population | Every adult patient presenting with either erythema migrans, borrelial lymphocytoma or acrodermatitis chronica atrophicans | ||||
| Condition | Lyme Borreliosis | ||||
| Intervention | Other: Cutaneous biopsy
Cutaneous biopsy in order to search Borrelia by means of culture and PCR in this tissue sample
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
900 | ||||
| Original Estimated Enrollment |
400 | ||||
| Estimated Study Completion Date | April 2022 | ||||
| Estimated Primary Completion Date | April 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion criteria:
Exclusion criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT00576082 | ||||
| Other Study ID Numbers | 3977 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | University Hospital, Strasbourg, France | ||||
| Study Sponsor | University Hospital, Strasbourg, France | ||||
| Collaborators | Société de Dermatologie Française | ||||
| Investigators |
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| PRS Account | University Hospital, Strasbourg, France | ||||
| Verification Date | April 2019 | ||||