Swiss ProspectivE Cohort of TRAnsgender and Gender Diverse Individuals - The SPECTRA Study

Официальное название

Swiss Prospective Cohort of TRAnsgender and Gender Diverse Individuals - The SPECTRA Study

Обзор

The goal of this observational study is to understand the factors influencing the well-being and health of transgender and gender-diverse (TGD) individuals undergoing gender-affirming therapies in Switzerland. The study population includes TGD individuals aged 16 and older, at various stages of their medical transition, including those who have discontinued or detransitioned. The main question is: What are the key factors influencing the well-being and health outcomes of transgender and gender-diverse individuals undergoing gender-affirming therapies? Researchers will compare health outcomes across different subgroups, such as those at different stages of transition or detransition, to examine the effects of gender-affirming therapies. Participants will: Complete electronic questionnaires assessing gender congruence, quality of life, mental health, and other outcomes. Provide biological samples (e.g., blood, urine, stool, and skin swabs) for laboratory analysis. Undergo clinical evaluations related to endocrinology, fertility, dermatology, and urology as part of their routine follow-up.

Вмешательства

• Другое Group A (start of GAHT)
  The study program consists of assessments at baseline (before the start of GAHT) and subsequent follow-up visits scheduled at routine intervals which are typically every three months for the first year, every six months for the second year and every twelve months thereafter. Participants' data collection includes a mix of digital and in-person methods. Demographical information, clinical and laboratory parameters such as hormone levels which are part of standard clinical care
• Другое Group B (on-going GAHT)
  The study program consists of a yearly assessment as part of the long-term routine follow-up. Participants' data collection includes a mix of digital and in-person methods. Demographical information, clinical and laboratory parameters such as hormone levels which are part of standard clinical care
• Другое Group C (GAS)
  If GAS is administered, additional assessments are performed preoperatively, and postoperatively in analogy with routine clinical visits, e.g. one week after surgery and then three, six and twelve months later (then once yearly) (e.g. type of surgery, outcome, patient' satisfaction). If participants undergo gender-affirming genital surgery, a genital swab and urine analysis (from the urine sample taken for routine testing) will additionally be performed for microbiome analyses as part of the stu

Первичные конечные точки

• Gender Congruence as Assessed by Gender Congruence and Life Satisfaction Scale (GCLS) [Срок оценки: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months]

Критерии участия

Критерии включения

• Age 16 years and above.
• Established diagnosis of gender incongruence
• Indication for gender affirming therapy or ongoing or discontinued gender affirming therapy

Критерии исключения

• Unable to give informed consent
• Missing commitment or ability to study protocol adherence

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 3 центра

• University Hospital of Basel — Basel
• Cantonal Hospital of Lucerne — Lucerne
• University Hospital of Zürich — Zurich

Идентификаторы

NCT: NCT06774053 · 2025-00514; kt24Winzeler

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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