Swiss Prospective Cohort of TRAnsgender and Gender Diverse Individuals - The SPECTRA Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 5
- 主要终点
- Gender Congruence as Assessed by Gender Congruence and Life Satisfaction Scale (GCLS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16 years and above.
- •Established diagnosis of gender incongruence
- •Indication for gender affirming therapy or ongoing or discontinued gender affirming therapy
排除标准
- •Unable to give informed consent
- •Missing commitment or ability to study protocol adherence
研究组 & 干预措施
Group C: Cohort of Transgender and Gender Diverse individuals in Switzerland
Individuals who undergo gender affirming surgery are (additionally or exclusively) included in group C
干预措施: Group C (GAS) (Other)
Group A: Cohort of Transgender and Gender Diverse individuals in Switzerland
Individuals who present before they start GAHT are included in group A
干预措施: Group A (start of GAHT) (Other)
Group B: Cohort of Transgender and Gender Diverse individuals in Switzerland
Individuals who are already on GAHT are included in group B
干预措施: Group B (on-going GAHT) (Other)
结局指标
主要结局
Gender Congruence as Assessed by Gender Congruence and Life Satisfaction Scale (GCLS)
时间窗: From enrollment to every routine follow-up assessment at baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, and annually thereafter
次要结局
未报告次要终点
研究者
Bettina Winzeler
PD Dr.
University Hospital, Basel, Switzerland