Clinical trial NCT06774053: Swiss ProspectivE Cohort of TRAnsgender and Gender Diverse Individuals - the SPECTRA Study
Official title: Swiss Prospective Cohort of TRAnsgender and Gender Diverse Individuals - the SPECTRA Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Transgender Individuals
Gender Incongruence
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Luzern
First posted: 2025-01-14
Enrollment: 600
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population for the SPECTRA study will consist of transgender and gender-diverse (TGD) individuals aged 16 and above, diagnosed with gender incongruence, and receiving care at participating Swiss healthcare centers. Recruitment will start at University Hospital Basel and Lucerne Cantonal Hospital and expand to other centers across Switzerland. 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.

Brief summary: 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: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Gender Congruence as Assessed by Gender Congruence and Life Satisfaction Scale (GCLS)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital of Basel
city: Lucerne
country: Switzerland
facility: Cantonal Hospital of Lucerne
Study officials:
References: