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

Not yet recruiting

• Conditions: Transgender Individuals; Gender Incongruence

• Registration Number: NCT06774053
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Study Start: 2025-01-30
• Primary Completion: 2045-01
• Study Completion: 2045-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (2)

University Hospital of Basel; 🇨🇭 Basel, Switzerland

Cantonal Hospital of Lucerne; 🇨🇭 Lucerne, Switzerland