Actively Recruiting
Swiss Prospective Cohort of Transgender and Gender Diverse Individuals The SPECTRA Study
Led by University Hospital, Basel, Switzerland · Updated on 2026-05-05
600
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
U
University of Luzern
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to better understand the well-being and health of transgender and gender-diverse individuals in Switzerland who are receiving or have received gender-affirming therapies. The study includes participants aged 16 and older at different stages of their medical transition, including those who have stopped or reversed their treatments. Researchers seek to identify key factors affecting health outcomes across these groups. Participants are divided into groups based on their transition stage: those who have not yet started gender-affirming hormone therapy (GAHT), those currently undergoing GAHT, and those who have undergone gender-affirming surgery (GAS). Assessments occur regularly, with more frequent visits early in hormone therapy and yearly follow-ups for longer-term monitoring. Surgery patients have additional evaluations before and after their operations, including specific sample collections for microbiome analyses. Throughout the study, participants complete electronic questionnaires on gender congruence, quality of life, and mental health. They provide biological samples such as blood, urine, stool, and skin swabs, and undergo clinical evaluations related to endocrinology, fertility, dermatology, and urology during routine follow-up visits. The main outcome measure is gender congruence assessed by a validated scale at multiple timepoints over up to 20 years. This long-term observation helps researchers track changes and factors influencing health and well-being.
CONDITIONS
Brief Title
Swiss ProspectivE Cohort of TRAnsgender and Gender Diverse Individuals - The SPECTRA Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 16 years and above
- Established diagnosis of gender incongruence
- Indication for gender affirming therapy or ongoing or discontinued gender affirming therapy
You will not qualify if you...
- Unable to give informed consent
- Missing commitment or ability to study protocol adherence
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Ongoing with visits typically every 3 months in the first year, every 6 months in the second year, and yearly thereafter.
Participants who start gender-affirming hormone therapy (GAHT) undergo assessments at baseline and follow-up visits as part of routine clinical care, including demographic information and clinical parameters such as hormone levels.
Baseline visit and follow-up visits approximately every 3 months for the first year, then every 6 months for the second year, and annually thereafter
Duration - Yearly assessments ongoing.
Participants already on GAHT have yearly assessments as part of long-term routine follow-up, including demographic and clinical data collection.
1 visit per year
Duration - From preoperative assessment to one year post-surgery with yearly visits thereafter.
Participants undergoing gender-affirming surgery receive additional assessments before surgery and post-operative visits in line with routine clinical care, including microbiome analyses from genital swabs and urine samples when applicable.
Preoperative visit, post-operative visits at 1 week, 3 months, 6 months, 12 months, then yearly
Trial Site Locations
Total: 2 locations
1
University Hospital of Basel
Basel, Switzerland, 4031
Actively Recruiting
2
Cantonal Hospital of Lucerne
Lucerne, Switzerland, 6000
Not Yet Recruiting
Research Team
B
Bettina Winzeler, PD Dr.
H
Hüseyin Cihan, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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