Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-01 @ 10:01 AM
Study NCT ID:
NCT02580760
Status:
COMPLETED
Last Update Posted:
2016-01-25
First Post:
2015-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transgender, Silicone and Blood Smear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D000075662', 'term': 'Injection Site Reaction'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005119', 'term': 'Extravasation of Diagnostic and Therapeutic Materials'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-22', 'studyFirstSubmitDate': '2015-09-30', 'studyFirstSubmitQcDate': '2015-10-18', 'lastUpdatePostDateStruct': {'date': '2016-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The prevalence of Transgender with circulating monocytes containing silicone vacuoles in blood smear among Male to Female Transgender population, the day of their consultation.', 'timeFrame': '1 day ,the day of their consultation', 'description': 'The prevalence of Transgender with circulating monocytes containing silicone vacuoles will be calculated as the number of subjects with monocytes containing silicone vacuoles in blood smears on the number of subjects with a history of silicone cosmetic injection'}], 'secondaryOutcomes': [{'measure': 'Number of monocytes with vacuoles of silicone in a standardized area of 25 monocytes per blood smear slide', 'timeFrame': '1 day ,the day of their consultation'}, {'measure': 'Size of silicone vacuoles in monocytes', 'timeFrame': '1 day ,the day of their consultation'}, {'measure': 'Inflammatory and not inflammatory dermatological complications', 'timeFrame': '1 day ,the day of their consultation', 'description': 'assessment of dermatological complications during the clinical examination'}, {'measure': 'Number of patients with a positive HIV status', 'timeFrame': '1 day ,the day of their consultation', 'description': 'Number of patients with a positive HIV status'}, {'measure': 'Level of immunosuppression estimated with viral charge', 'timeFrame': '1 day ,the day of their consultation', 'description': 'HIV viral load, the day of the admission or the last value known in the 6 month prior to the consultation'}, {'measure': 'Level of immunosuppression estimated with cluster of differentiation 4 cell (CD4) rate', 'timeFrame': '1 day ,the day of their consultation', 'description': 'CD4 cell count the day of the consultation or the last value known in the 6 month prior to the consultation.\n\nCD4 cell stands for Cluster of differentiation antigen 4 cell.'}, {'measure': 'Inflammatory syndrome estimated with C-reactive protein (CRP)', 'timeFrame': '1 day ,the day of their consultation'}, {'measure': 'Inflammatory syndrome estimated with ferritin', 'timeFrame': '1 day ,the day of their consultation'}, {'measure': 'Amount of injected silicone, in liters', 'timeFrame': '1 day ,the day of their consultation'}, {'measure': 'Time since the first silicone injection for cosmetic purposes, in years', 'timeFrame': '1 day ,the day of their consultation'}, {'measure': 'Comorbidities: Number of patients with history of Tuberculosis', 'timeFrame': '1 day ,the day of their consultation', 'description': 'Number of patients with history of Tuberculosis'}, {'measure': 'Comorbidities: Number of patients with history of Hepatitis B', 'timeFrame': '1 day ,the day of their consultation', 'description': 'Number of patients with history of Hepatitis B'}, {'measure': 'Comorbidities: Number of patients with history of Hepatitis C', 'timeFrame': '1 day ,the day of their consultation', 'description': 'Number of patients with history of Hepatitis C'}, {'measure': 'Comorbidities: Number of patients with history of Syphilis', 'timeFrame': '1 day ,the day of their consultation', 'description': 'Number of patients with history of Syphilis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Silicone', 'Transgender', 'Dermatology', 'Blood contamination', 'Adverse event after injection'], 'conditions': ['Injection; Complications, Sepsis', 'Injection Site Disorder', 'Injection Site Extravasation', 'Intentional Poisoning by Silicone']}, 'descriptionModule': {'briefSummary': 'This cross-sectional monocentric study will describe transgender men transitioning into women and who had cosmetic silicone injection.\n\nThe 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.\n\nThe 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).', 'detailedDescription': 'Injectable liquid silicone is a permanent filling product which is no more used in France because of a high risk of complications. Cosmetic silicone injection is a common feminization approach for transgender populations.\n\nThis cross-sectional monocentric study will describe transgender men transitioning into women and who had cosmetic silicone injection.\n\nThe 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.\n\nThe 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).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Every transgender men transitioning into women patients with cosmetic silicone injection and consulting in Bichat hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults\n* Not in opposition to data collection\n* Transgender men transitioning into women patients with cosmetic silicone injection\n* Consultation in Bichat hospital\n\nExclusion Criteria:\n\n* Unable to communicate\n* Guardianship, curatorship'}, 'identificationModule': {'nctId': 'NCT02580760', 'acronym': 'TSBS', 'briefTitle': 'Transgender, Silicone and Blood Smear', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Circulating Silicone After Cosmetic Silicone Injection in Transgender Patients', 'orgStudyIdInfo': {'id': '15FBT-TSBS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cosmetic silicone injection', 'description': 'People responding to inclusion criteria with a history of cosmetic silicone injection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpitaux Universitaires Paris-Nord Val de Seine, site Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Fabrice Bouscarat, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hôpitaux Universitaires Paris-Nord Val de Seine, site Bichat'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}