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

NCT ID: NCT06774053

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-30

Study Completion Date

2045-01-31

Brief Summary

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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

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Conditions

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Transgender Individuals Gender Incongruence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort of Transgender and Gender Diverse individuals in Switzerland

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Luzern

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Bettina Winzeler

PD Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital of Basel

Basel, , Switzerland

Site Status

Cantonal Hospital of Lucerne

Lucerne, , Switzerland

Site Status

Countries

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Switzerland

Central Contacts

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Bettina Winzeler, PD Dr.

Role: CONTACT

+41763584034

Hüseyin Cihan, Dr.

Role: CONTACT

Facility Contacts

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Bettina Winzeler

Role: primary

+41763584034

Lea Slahor, KD Dr.

Role: primary

+41 205 51 03

Other Identifiers

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2025-00018

Identifier Type: -

Identifier Source: org_study_id

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