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

NCT06774053 | Recruiting

• 1 other identifier: 2025-00514; kt24Winzeler
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

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.

Conditions

Transgender Individuals; Gender Incongruence

Keywords

Gender Affirming Hormone Therapy (GAHT); Gender Affirming Surgery (GAS); Transgender and Gender Diverse (TGD)

Outcome Measures

Primary Outcomes (1)

• Gender Congruence as Assessed by Gender Congruence and Life Satisfaction Scale (GCLS)

  The Gender Congruence and Life Satisfaction Scale (GCLS) is a validated outcome measure specifically developed for transgender individuals to assess distress and unhappiness with experienced gender and body, regardless of gender assigned at birth or gender identity. The scale ranges from \[insert range, e.g., 0-100\], with higher scores indicating greater gender congruence and life satisfaction, and lower scores reflecting greater distress and unhappiness. It is suitable for binary and nonbinary individuals seeking gender-affirming care.

  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

Other Outcomes (38)

• Gender identity

  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

• Difference in Gender Affirming Hormone Therapy (GAHT) regimens

  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

• Decision regret scale

  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

Study Arms (3)

Group A: Cohort of Transgender and Gender Diverse individuals in Switzerland

Individuals who present before they start GAHT are included in group A

Other: Group A (start of GAHT)

Group B: Cohort of Transgender and Gender Diverse individuals in Switzerland

Individuals who are already on GAHT are included in group B

Other: Group B (on-going GAHT)

Group C: Cohort of Transgender and Gender Diverse individuals in Switzerland

Individuals who undergo gender affirming surgery are (additionally or exclusively) included in group C

Other: Group C (GAS)

Interventions

Group B (on-going GAHT) OTHER

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

Group B: Cohort of Transgender and Gender Diverse individuals in Switzerland

Group C (GAS) OTHER

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.

Group C: Cohort of Transgender and Gender Diverse individuals in Switzerland

Group A (start of GAHT) OTHER

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

Group A: Cohort of Transgender and Gender Diverse individuals in Switzerland

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The project population will consist of TGD individuals above age 16 who are diagnosed with gender incongruence and who wish medical transition or are on medical transition (at any stage of their transition, including individuals who interrupt/-ed medical transition or detransition/-ed). Recruitment for the study will initially take place at the University Hospital of Basel and the Cantonal Hospital of Luzern, with plans to expand to additional centers (e.g. University Hospital of Zurich, University Hospital of Geneva and Cantonal Hospital of St Gallen) as the study progresses. The study targets individuals at various stages of medical transition, including those initiating, continuing, or discontinuing gender-affirming therapies. Efforts will ensure inclusion of all gender identities to comprehensively address their unique healthcare needs.

You may qualify if:

• Age 16 years and above.
• Established diagnosis of gender incongruence
• Indication for gender affirming therapy or ongoing or discontinued gender affirming therapy

You may not qualify if:

• Unable to give informed consent
• Missing commitment or ability to study protocol adherence

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University of Luzern: collaborator

Study Sites (2)

University Hospital of Basel

Basel, 4031, Switzerland

RECRUITING

Cantonal Hospital of Lucerne

Lucerne, 6000, Switzerland

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biobank blood sampling; 24h-Urine; Scalp hair analysis; Spermanalysis; Stool sampling

MeSH Terms

Conditions

Gender Dysphoria

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Bettina Winzeler, PD Dr.

  University Hospital Basel, Department of Endocrinology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bettina Winzeler, PD Dr.

CONTACT

+41 61 556 50 75; bettina.winzeler@usb.ch

Hüseyin Cihan, Dr.

CONTACT

hueseyin.cihan@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr.

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 14, 2025
• Study Start: April 20, 2026
• Primary Completion (Estimated): January 1, 2046
• Study Completion (Estimated): January 1, 2046
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CH (2)