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RECRUITING
NCT06774053

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

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2026-04-20

Completion Date

2046-01

Last Updated

2026-05-05

Healthy Volunteers

No

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 study assessment.

Locations (2)

University Hospital of Basel

Basel, Switzerland

Cantonal Hospital of Lucerne

Lucerne, Switzerland