Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT07163832
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2025-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Study of the Cohort of Transgender Patients Who Began Medical Support Before the Age of 18
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2025-09-01', 'studyFirstSubmitQcDate': '2025-09-01', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retrospective descriptive study of the population of transgender minors receiving medical support at the Strasbourg University Hospital', 'timeFrame': 'Up to 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric endocrinology', 'Child Psychiatry'], 'conditions': ['Endocrinology']}, 'descriptionModule': {'briefSummary': 'Gender incongruence is characterized by a marked and persistent incongruity between the gender with which a person identifies and their assigned sex. Behaviors and preferences that vary by sex do not, in and of themselves, justify the assignment of diagnoses in this group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Minor patient (≥18 years old) who has been consulted for the first time for transgender issues at the Strasbourg University Hospital in child psychiatry and/or pediatric endocrinology (in at least one of the two departments)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minor patient (≥18 years old)\n* First-time patient for transgender issues at the Strasbourg University Hospital in child psychiatry and/or pediatric endocrinology (in at least one of the two departments)\n* Patient (and/or their legal representative) who has not expressed opposition to the reuse of their data for scientific research purposes.\n\nExclusion Criteria:\n\n* Patient (and/or their representative) who has expressed opposition to the reuse of their data for scientific research purposes.\n* Patient aged over 18 at the first consultation\n* Patient with insufficient data'}, 'identificationModule': {'nctId': 'NCT07163832', 'acronym': 'TRANS', 'briefTitle': 'Retrospective Study of the Cohort of Transgender Patients Who Began Medical Support Before the Age of 18', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Retrospective Single-center Study of the Cohort of Transgender Patients Who Began Medical Support Before the Age of 18 at the Strasbourg University Hospital', 'orgStudyIdInfo': {'id': '9688'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François BREZIN, MD', 'role': 'CONTACT', 'email': 'francois.brezin@chru-strasbourg.fr', 'phone': '03.88.12.77.34'}, {'name': 'François BREZIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Camille SCHUNDER, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Agnes GRAS-VINCENDON, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service de pédiatrie 1 - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'François BREZIN, MD', 'role': 'CONTACT', 'email': 'francois.brezin@chru-strasbourg.fr', 'phone': '03.88.12.77.34'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}