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Švýcarská perspektivní kohorta TRAnsgender a genderově různorodých jedinců – studie SPECTRA (SPECTRA)

28. dubna 2026 aktualizováno: Bettina Winzeler, University Hospital, Basel, Switzerland

Švýcarská prospektivní kohorta TRAnsgender a genderově různorodých jedinců - studie SPECTRA

Cílem této observační studie je porozumět faktorům ovlivňujícím pohodu a zdraví transgender a gender-diverse (TGD) jedinců, kteří ve Švýcarsku podstupují genderově potvrzující terapie. Populace studie zahrnuje jedince s TGD ve věku 16 let a starší, v různých fázích jejich lékařského přechodu, včetně těch, kteří přerušili léčbu nebo ukončili transmisi.

Hlavní otázka zní:

Jaké jsou klíčové faktory ovlivňující blahobyt a zdravotní výsledky transgender a genderově různorodých jedinců, kteří podstupují genderově potvrzující terapie?

Výzkumníci budou porovnávat zdravotní výsledky napříč různými podskupinami, jako jsou ty v různých fázích přechodu nebo detranspozice, aby prozkoumali účinky terapií potvrzujících pohlaví.

Účastníci budou:

Vyplňte elektronické dotazníky hodnotící genderovou shodu, kvalitu života, duševní zdraví a další výsledky.

Poskytněte biologické vzorky (např. krev, moč, stolici a kožní výtěry) pro laboratorní analýzu.

Podstupují klinická hodnocení týkající se endokrinologie, fertility, dermatologie a urologie jako součást jejich rutinního sledování.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Odhadovaný)

600

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Švýcarsko
      • Basel, Švýcarsko, 4031
        • Nábor
        • University Hospital of Basel
        • Kontakt:
      • Lucerne, Švýcarsko, 6000
        • Zatím nenabíráme
        • Cantonal Hospital of Lucerne
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Populace studie pro studii SPECTRA se bude skládat z transgender a genderově různorodých (TGD) jedinců ve věku 16 a více let, u kterých byla diagnostikována genderová inkongruence a kterým bude poskytnuta péče v zúčastněných švýcarských zdravotnických centrech. Nábor začne v Univerzitní nemocnici v Basileji a Lucerne Cantonal Hospital a rozšíří se do dalších center po celém Švýcarsku. Studie se zaměřuje na jedince v různých fázích přechodu na léčbu, včetně těch, kteří zahajují, pokračují nebo ukončují terapie potvrzující pohlaví. Úsilí zajistí začlenění všech genderových identit s cílem komplexně řešit jejich jedinečné potřeby v oblasti zdravotní péče.

Popis

Kritéria zahrnutí:

  • Věk 16 let a více.
  • Stanovená diagnóza genderové inkongruence
  • Indikace pro genderovou potvrzovací terapii nebo probíhající či přerušenou genderovou potvrzovací terapii

Kritéria vyloučení:

  • Nelze dát informovaný souhlas
  • Chybějící závazek nebo schopnost studovat dodržování protokolu

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Group A: Cohort of Transgender and Gender Diverse individuals in Switzerland
Individuals who present before they start GAHT are included in group A
Jiný: 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
Group B: Cohort of Transgender and Gender Diverse individuals in Switzerland
Individuals who are already on GAHT are included in group B
Jiný: 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
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
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Gender Congruence as Assessed by Gender Congruence and Life Satisfaction Scale (GCLS)
Časové okno: 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
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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Gender identity
Časové okno: 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
The gender identity is assessed using a study-specific questionnaire to determine the percentage of different gender identities (e.g. binary, non-binary) and change of gender identity over time
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
Časové okno: 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
The reported value will be the number and percentage of participants receiving each documented GAHT regimen category at each routine assessment, stratified by self-reported 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
Decision regret scale
Časové okno: 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
The Decision Regret Scale is a validated tool that is used in this study to measure the regret after detransition. The scale ranges from 0 to 100, with higher scores indicating greater regret and lower scores reflecting less or no regret. It is widely applicable across different healthcare contexts to assess the emotional impact of decision-making.
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
Body image states scale
Časové okno: 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
The Body Image States Scale is a validated measure that is used in this study to assess an individual's momentary body image satisfaction after detransition. The scale ranges from 0 to X, with higher scores indicating greater body image satisfaction and lower scores reflecting greater dissatisfaction.
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
Quality of life score
Časové okno: 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
The quality of life is meassured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire.The EQ-5D-5L is a standardized measure, assessing mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale provides a utility score ranging from 0 (equivalent to death) to 1 (perfect health), with higher scores indicating better health-related quality of life.
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
Treatment Satisfaction Questionnaire for Medication 1.4
Časové okno: 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
To evaluate treatment satisfaction an adapted Treatment Satisfaction Questionnaire for Medication 1.4 (TSQM-1.4) is used. TSQM-1.4 is a validated tool, assessing patients' satisfaction with their treatments across four domains: effectiveness, side effects, convenience, and overall satisfaction. The scale provides scores ranging from 0 to 100 for each domain, with higher scores indicating greater satisfaction.
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
Beck Depression Inventory-II
Časové okno: 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
The Beck Depression Inventory-II (BDI-II), a validated self-report measure, is used to assess depressive symptoms. The scale ranges from 0 to 63, with higher scores indicating greater severity of depressive symptoms and lower scores reflecting minimal or no depression.
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
Detransition rate
Časové okno: 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
Detransition is assessed as the percentage of individuals who interrupt or stop therapy over time.
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
Reasons for stopping/reversing transition
Časové okno: 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
The reasons for stopping/reversing transition is assessed using a questionnaire adapted from MacKinnon et al., 2024 (21 possible reasons for stopping/reversing transition).
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
Gender Minority Stress and Resilience Measure
Časové okno: 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
The Gender Minority Stress and Resilience Measure (GMSR) is a validated, assessing experiences of minority stress and resilience factors specific to transgender and gender-diverse individuals. The scale includes multiple subscales with scores reflecting the levels of stress (e.g., discrimination, internalized transphobia) and resilience (e.g., community connectedness, pride). Higher stress subscale scores indicate greater experiences of minority stress, while higher resilience subscale scores reflect stronger protective factors.
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
Endocrine profiling
Časové okno: 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
Sex hormone are profiled on GAHT and in relation to the different outcome measures
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
Blood pressure
Časové okno: 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
Blood pressure is taken (by unattended automated office blood pressure measurement =UAOBPM)
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
Body mass index
Časové okno: 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
Body weight is measured and body mass index (BMI) calculated.
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
Dietary Approaches to Stop Hypertension (DASH) score
Časové okno: 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
Dietary quality is assessed via Dietary Approaches to Stop Hypertension (DASH) scoring on a scale from 1-100, with higher score indicating healthier dietary habits.
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
Mediterranean Eating Pattern (MEPA) score
Časové okno: 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
Dietary quality is assessed via Mediterranean Eating Pattern (MEPA) scoring on a scale from 1-100, with higher score indicating healthier dietary habits.
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
Lipid profile
Časové okno: 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
Glucose homesostasis is assessed by measuring blood glucose, HOMA-Index, HbA1C.
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
Inflammation hsCRP
Časové okno: 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
hsCRP concentration measured in venous blood as part of routine laboratory assessment and reported as a continuous variable
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
Inflammation IL-6
Časové okno: 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
Inflammatory markers are assessed including IL-6
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
Health risk behaviors
Časové okno: 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
National Health and Nutrition Examination Survey (NHANES) questionnaires assesses smoking, alcohol, physical activity.
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
Sleep quality
Časové okno: 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
Pittsburgh Sleep Quality Index (PSQI) which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
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
Insomnia
Časové okno: 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
Insomnia Severity Index (ISI) is a self-assessment questionnaire ranging from 0-28, while higher score worse sleep quality
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
Scalp hair cortisol concentration measured by liquid chromatography-tandem mass spectrometry
Časové okno: Baseline and 12 months after initiation of GAHT
Cortisol concentration measured in a proximal 3-cm scalp hair segment collected from the posterior vertex region
Baseline and 12 months after initiation of GAHT
Urinary steroid profile
Časové okno: Baseline and 12 months after initiation of GAHT
Steroid profile measured in a 24-hour urine sample to capture integrated steroid excretion over 24 hours.
Baseline and 12 months after initiation of GAHT
Immunological parameters cytokine levels
Časové okno: 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
IL-6, TNF-α, IL-1β, IL-10 concentration measured in stored blood samples and reported as a continuous variable.
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
Immunological parameters antibody levels
Časové okno: 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
Assessment of antibody levels
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
Fertility Self-Assessment Responses Assessed Using a SPECTRA-Specific Questionnaire
Časové okno: 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
The reported value will be the number and percentage of participants selecting each response category for prespecified fertility-related items, including fertility intentions, prior fertility preservation, interest in future fertility preservation, and fertility-related counseling needs, as assessed using a SPECTRA-specific self-assessment questionnaire. This study-specific questionnaire is not summarized as a total score.
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
Tucking practices
Časové okno: 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
The reported value will be the number and percentage of participants who report current tucking practices on the SPECTRA questionnaire.
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
Sexual Desire
Časové okno: 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
Sexual Desire Inventory (SDI). The scores for the two dimensions of sexual desire are summed up separately. Dyadic sexual desire: Scores will range from 0 to 62; while there is no universally established cutoff score that applies across all populations, higher scores at around 50 and upward indicate hypersexuality in the dyadic dimension. Solitary sexual desire: Scores will range from 0 to 39; while there is no universally established cutoff score that applies across all populations, higher scores at around 31 and upward indicate hypersexuality in the solitary dimension.
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
Semen Quality Status
Časové okno: 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
The reported value will be the number and percentage of eligible participants in each predefined semen quality category at each assessment time point. Semen quality status will be derived from standard semen analysis parameters according to prespecified laboratory criteria and categorized as normal semen quality, impaired semen quality, severe impairment, azoospermia, or not classifiable due to insufficient sample quality or missing parameters.
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
Dermatology life quality index
Časové okno: 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
Dermatology life quality index (DLQI) is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
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
Visual analogue scale disease activity
Časové okno: 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
disease activity is assessed by Visual analogue scale (VAS)
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
Percentage of scalp hairs
Časové okno: 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
Percentage of hairs with reduced caliber assessed using TrichoScan software in a circular 1-cm² scalp area.
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
Skin aging assessed by VISIA skin analysis
Časové okno: 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
For the detection of skin wrinkles Visia device will be used as standardized photography
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
Skin microbiome
Časové okno: 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
Skin swabs from defined sites to perform 16S rRNA amplicon based sequencing of the cutaneous bacterial microbiome
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
Prosthesis outcome
Časové okno: 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
In transmen, prosthesis outcome is assessed including complication rates, revision rates, survival rates, patient- and partner-related satisfaction rate e.g. with validated Questionnaire Quality of Life and Sexuality with Penile Prosthesis (QoLSPP)
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
Urethral Complication Status Assessed by Clinical Examination
Časové okno: 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
The reported value will be the number and percentage of eligible participants in each predefined urethral complication category at each assessment time point, as assessed by clinical examination and medical record review. Categories will include no urethral complication, urethral stricture, urethral fistula, both urethral stricture and fistula, and other urethral complication. For participants with urethral stricture or fistula, the type of management will be recorded descriptively according to predefined categories, including conservative management, catheter-based management, endoscopic treatment, surgical repair, or other management.
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
Lower Urinary Tract Symptom Questionnaire
Časové okno: 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
Lower Urinary Tract Symptom Questionnaire is a self-assessment tool to grade lower urinary tract symptoms. It ranges from 0-35, while typically a score of 0-7 indicates mild symptoms, 8-19 moderate symptoms and 20-35 severe symptoms. Higher scores indicate more severe symptoms.
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
Gut microbiome
Časové okno: 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
Alpha diversity, beta diversity, microbial richness and relative abundance diversity of the gut microbiome measured in stool samples and reported using a predefined diversity index.
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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University Hospital, Basel, Switzerland

Spolupracovníci

University of Luzern

Vyšetřovatelé

  • Vrchní vyšetřovatel: Bettina Winzeler, PD Dr., University Hospital Basel, Department of Endocrinology

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

20. dubna 2026

Primární dokončení (Odhadovaný)

1. ledna 2046

Dokončení studie (Odhadovaný)

1. ledna 2046

Termíny zápisu do studia

První předloženo

8. ledna 2025

První předloženo, které splnilo kritéria kontroly kvality

8. ledna 2025

První zveřejněno (Aktuální)

14. ledna 2025

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2025-00514; kt24Winzeler

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Group A (start of GAHT)

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Mongolia

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit