Swiss prospective cohort of transgender and gender-diverse people
Swiss Prospective Cohort of TRAnsgender and Gender Diverse Individuals - The SPECTRA Study
This project tests which social, medical, and biological factors are linked to health and well-being in transgender and gender-diverse people in Switzerland who are starting, undergoing, or have stopped gender-affirming care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 2 sites (Basel and 1 other locations) |
| Trial ID | NCT06774053 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort enrolling transgender and gender-diverse individuals aged 16 and older across Swiss centers. Participants complete regular electronic questionnaires on gender congruence, quality of life, and mental health while providing biological samples such as blood, urine, stool, and skin swabs. Researchers will compare outcomes across subgroups (e.g., starting GAHT, ongoing GAHT, post-GAS, or detransitioned) to identify factors associated with better or worse health. Clinical data from participating hospitals will be combined with laboratory analyses to explore biological correlates of reported outcomes.
Who should consider this trial
Good fit: Ideal candidates are transgender and gender-diverse individuals aged 16 or older with a diagnosis of gender incongruence who are initiating, currently receiving, or have discontinued gender-affirming therapies and can give informed consent.
Not a fit: People who cannot give informed consent, are unable or unwilling to adhere to follow-up questionnaires and sample collection, or who do not have a diagnosis of gender incongruence are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the work could help tailor gender-affirming care and support services to improve mental and physical health for transgender and gender-diverse patients.
How similar studies have performed: Previous research has shown mental health benefits from gender-affirming hormone therapy, but comprehensive longitudinal cohorts linking patient-reported outcomes with broad biological sampling are less common.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basel and 1 other locations
- University Hospital of Basel — Basel, Switzerland (Recruiting)
- Cantonal Hospital of Lucerne — Lucerne, Switzerland (Not_yet_recruiting)
Study contacts
- Principal investigator: Bettina Winzeler, PD Dr. — University Hospital Basel, Department of Endocrinology
- Study coordinator: Bettina Winzeler, PD Dr.
- Email: bettina.winzeler@usb.ch
- Phone: +41 61 556 50 75
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.