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Recruiting NCT06774053

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

— Observational Transgender Individuals Gender Incongruence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group A (start of GAHT), Group B (on-going GAHT), Group C (GAS).
Who it may be relevant to
Registry conditions: Transgender Individuals, Gender Incongruence. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other 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
  • Other 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
  • Other 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

Primary outcome measures

  • Gender Congruence as Assessed by Gender Congruence and Life Satisfaction Scale (GCLS) [Time frame: 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 3 centers
  • University Hospital of Basel — Basel
  • Cantonal Hospital of Lucerne — Lucerne
  • University Hospital of Zürich — Zurich

Identifiers

NCT: NCT06774053 · 2025-00514; kt24Winzeler

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗