Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
66 participants
OBSERVATIONAL
2015-07-31
2016-01-31
Brief Summary
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The principal objective is to estimate the prevalence of Transgender with circulating monocytes containing silicone vacuoles in blood smears among Male to Female Transgender population with a history of cosmetic silicon injections.
The secondary objectives are to describe the transgender population, to describe the quantity of silicone in vacuoles of circulating monocytes, and the association between dermatological complications (inflammatory and not inflammatory) and several clinical and biological characteristics (HIV status, level of immunosuppression, inflammatory syndrome, quantity of silicone which was injected , silicone quantity in blood smears).
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Detailed Description
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This cross-sectional monocentric study will describe transgender men transitioning into women and who had cosmetic silicone injection.
The principal objective is to estimate the prevalence of Transgender with circulating monocytes containing silicone vacuoles in blood smears among Male to Female Transgender population with a history of cosmetic silicon injections.
The secondary objectives are to describe the transgender population, to describe the quantity of silicone in vacuoles of circulating monocytes, and the association between dermatological complications (inflammatory and not inflammatory) and several clinical and biological characteristics (HIV status, level of immunosuppression, inflammatory syndrome, quantity of silicone which was injected , silicone quantity in blood smears).
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Cosmetic silicone injection
People responding to inclusion criteria with a history of cosmetic silicone injection
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Not in opposition to data collection
* Transgender men transitioning into women patients with cosmetic silicone injection
* Consultation in Bichat hospital
Exclusion Criteria
* Guardianship, curatorship
18 Years
MALE
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Fabrice Bouscarat, MD
Role: STUDY_DIRECTOR
Hôpitaux Universitaires Paris-Nord Val de Seine, site Bichat
Locations
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Hôpitaux Universitaires Paris-Nord Val de Seine, site Bichat
Paris, , France
Countries
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Other Identifiers
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15FBT-TSBS
Identifier Type: -
Identifier Source: org_study_id
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