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

ConditionsTransgender Individuals Gender Incongruence

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age16+

SponsorUniversity Hospital, Basel, Switzerland

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 16 years and above.

Established diagnosis of gender incongruence

Indication for gender affirming therapy or ongoing or discontinued gender affirming therapy

Disqualifiers

Unable to give informed consent

Missing commitment or ability to study protocol adherence

Trial population

The project population will consist of TGD individuals above age 16 who are diagnosed with gender incongruence and who wish medical transition or are on medical transition (at any stage of their transition, including individuals who interrupt/-ed medical transition or detransition/-ed). Recruitment for the study will initially take place at the University Hospital of Basel and the Cantonal Hospital of Luzern, with plans to expand to additional centers (e.g. University Hospital of Zurich, University Hospital of Geneva and Cantonal Hospital of St Gallen) as the study progresses. The study targets individuals at various stages of medical transition, including those initiating, continuing, or discontinuing gender-affirming therapies. Efforts will ensure inclusion of all gender identities to comprehensively address their unique healthcare needs.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Group A (start of GAHT)
Other intervention
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
Group B (on-going GAHT)
Other intervention
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
Group C (GAS)
Other intervention
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 study assessment.

Treatment groups

600 Participants

are divided into 3 treatment groups

Group A: Group A: Cohort of Transgender and Gender Diverse individuals in Switzerland1 intervention

Group B: Group B: Cohort of Transgender and Gender Diverse individuals in Switzerland1 intervention

Group C: Group C: Cohort of Transgender and Gender Diverse individuals in Switzerland1 intervention

Trial outcomes

Primary outcomes

Gender Congruence as Assessed by Gender Congruence and Life Satisfaction Scale (GCLS)

The Gender Congruence and Life Satisfaction Scale (GCLS) is a validated outcome measure specifically developed for transgender individuals to assess distress and unhappiness with experienced gender and body, regardless of gender assigned at birth or gender identity. The scale ranges from \[insert range, e.g., 0-100\], with higher scores indicating greater gender congruence and life satisfaction, and lower scores reflecting greater distress and unhappiness. It is suitable for binary and nonbinary individuals seeking gender-affirming care.

Time frame