트랜스젠더 및 성별이 다양한 개인으로 구성된 스위스 ProspectivE 코호트 - SPECTRA 연구 (SPECTRA)
2026년 6월 26일 업데이트: Bettina Winzeler, University Hospital, Basel, Switzerland
TRAnsgender 및 성별이 다양한 개인의 스위스 유망 코호트 - SPECTRA 연구
이 관찰 연구의 목표는 스위스에서 성전환 치료를 받고 있는 트랜스젠더 및 성별 다양성(TGD) 개인의 웰빙과 건강에 영향을 미치는 요인을 이해하는 것입니다. 연구 모집단에는 중단 또는 전환을 중단한 사람들을 포함하여 다양한 의료 전환 단계에 있는 16세 이상의 TGD 개인이 포함됩니다.
주요 질문은 다음과 같습니다.
성전환 치료를 받는 트랜스젠더와 성별이 다양한 개인의 웰빙과 건강 결과에 영향을 미치는 주요 요인은 무엇입니까?
연구자들은 다양한 전환 또는 전환 단계에 있는 그룹과 같은 다양한 하위 그룹의 건강 결과를 비교하여 성별 확인 치료법의 효과를 조사할 것입니다.
참가자는 다음을 수행합니다.
성별 일치, 삶의 질, 정신 건강 및 기타 결과를 평가하는 전자 설문지를 작성하세요.
실험실 분석을 위해 생물학적 샘플(예: 혈액, 소변, 대변, 피부 면봉)을 제공합니다.
일상적인 후속 조치의 일환으로 내분비학, 생식력, 피부과, 비뇨기과와 관련된 임상 평가를 받습니다.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
관찰
등록 (추정된)
등록
600
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Hüseyin Cihan, Dr.
- 이메일: hueseyin.cihan@usb.ch
연구 연락처 백업
- 이름: Bettina Winzeler, PD Dr.
- 전화번호: +41 61 556 50 75
- 이메일: bettina.winzeler@usb.ch
연구 장소
-
-
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Basel, 스위스, 4031
- 모병
- University Hospital of Basel
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연락하다:
- Bettina Winzeler, PD Dr. med.
- 전화번호: +41 61 556 50 75
- 이메일: bettina.winzeler@usb.ch
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Lucerne, 스위스, 6000
- 아직 모집하지 않음
- Cantonal Hospital of Lucerne
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연락하다:
- Lea Slahor, KD Dr.
- 전화번호: +41 205 51 03
- 이메일: lea.slahor@luks.ch
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Zurich, 스위스, 8091
- 아직 모집하지 않음
- University Hospital of Zurich
-
연락하다:
- Bettina Winzeler, PD Dr. med.
- 전화번호: +41 44 255 36 20
- 이메일: bettina.winzeler@usb.ch
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
SPECTRA 연구의 연구 모집단은 성별 불일치 진단을 받고 참여하는 스위스 의료 센터에서 치료를 받고 있는 16세 이상의 트랜스젠더 및 성별 다양성(TGD) 개인으로 구성됩니다.
모집은 바젤 대학병원과 루체른 칸토날 병원에서 시작하여 스위스 전역의 다른 센터로 확대될 예정입니다.
이 연구는 성전환 치료를 시작, 지속, 중단하는 등 의료 전환의 다양한 단계에 있는 개인을 대상으로 합니다.
모든 성 정체성을 포괄하여 고유한 의료 요구 사항을 종합적으로 해결하려는 노력을 기울일 것입니다.
설명
포함 기준:
- 16세 이상.
- 성별 불일치 진단 확립
- 성별 확인 치료 또는 진행 중이거나 중단된 성별 확인 치료에 대한 적응증
제외 기준:
- 사전 동의를 제공할 수 없음
- 프로토콜 준수를 연구하기 위한 헌신이나 능력이 부족함
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
3
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
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Group A: Cohort of Transgender and Gender Diverse individuals in Switzerland
Individuals who present before they start GAHT are included in group A
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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
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Group B: Cohort of Transgender and Gender Diverse individuals in Switzerland
Individuals who are already on GAHT are included in group B
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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
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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
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gender Congruence as Assessed by Gender Congruence and Life Satisfaction Scale (GCLS)
기간: 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
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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.
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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
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gender identity
기간: 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
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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
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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
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Difference in Gender Affirming Hormone Therapy (GAHT) regimens
기간: 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
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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.
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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
|
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Decision regret scale
기간: 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
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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.
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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
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Body image states scale
기간: 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
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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.
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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
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Quality of life score
기간: 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
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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.
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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
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Treatment Satisfaction Questionnaire for Medication 1.4
기간: 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
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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.
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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
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Beck Depression Inventory-II
기간: 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
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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.
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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
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Detransition rate
기간: 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
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Detransition is assessed as the percentage of individuals who interrupt or stop therapy over time.
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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
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Reasons for stopping/reversing transition
기간: 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
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The reasons for stopping/reversing transition is assessed using a questionnaire adapted from MacKinnon et al., 2024 (21 possible reasons for stopping/reversing transition).
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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
|
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Gender Minority Stress and Resilience Measure
기간: 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
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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.
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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
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Endocrine profiling
기간: 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
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Sex hormone are profiled on GAHT and in relation to the different outcome measures
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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
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Blood pressure
기간: 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
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Blood pressure is taken (by unattended automated office blood pressure measurement =UAOBPM)
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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
|
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Body mass index
기간: 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
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Body weight is measured and body mass index (BMI) calculated.
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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
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Dietary Approaches to Stop Hypertension (DASH) score
기간: 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
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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.
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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
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Mediterranean Eating Pattern (MEPA) score
기간: 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
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Dietary quality is assessed via Mediterranean Eating Pattern (MEPA) scoring on a scale from 1-100, with higher score indicating healthier dietary habits.
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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
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Lipid profile
기간: 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
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Glucose homesostasis is assessed by measuring blood glucose, HOMA-Index, HbA1C.
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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
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Inflammation hsCRP
기간: 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
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hsCRP concentration measured in venous blood as part of routine laboratory assessment and reported as a continuous variable
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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
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Inflammation IL-6
기간: 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
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Inflammatory markers are assessed including IL-6
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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
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Health risk behaviors
기간: 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
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National Health and Nutrition Examination Survey (NHANES) questionnaires assesses smoking, alcohol, physical activity.
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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
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Sleep quality
기간: 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
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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.
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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
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Insomnia
기간: 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
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Insomnia Severity Index (ISI) is a self-assessment questionnaire ranging from 0-28, while higher score worse sleep quality
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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
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Scalp hair cortisol concentration measured by liquid chromatography-tandem mass spectrometry
기간: Baseline and 12 months after initiation of GAHT
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Cortisol concentration measured in a proximal 3-cm scalp hair segment collected from the posterior vertex region
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Baseline and 12 months after initiation of GAHT
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Urinary steroid profile
기간: Baseline and 12 months after initiation of GAHT
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Steroid profile measured in a 24-hour urine sample to capture integrated steroid excretion over 24 hours.
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Baseline and 12 months after initiation of GAHT
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Immunological parameters cytokine levels
기간: 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
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IL-6, TNF-α, IL-1β, IL-10 concentration measured in stored blood samples and reported as a continuous variable.
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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
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Immunological parameters antibody levels
기간: 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
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Assessment of antibody levels
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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
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Fertility Self-Assessment Responses Assessed Using a SPECTRA-Specific Questionnaire
기간: 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
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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.
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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
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Tucking practices
기간: 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
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The reported value will be the number and percentage of participants who report current tucking practices on the SPECTRA questionnaire.
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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
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Sexual Desire
기간: 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
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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.
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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
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|
Semen Quality Status
기간: 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
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Dermatology life quality index
기간: 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
|
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Visual analogue scale disease activity
기간: 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
|
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Percentage of scalp hairs
기간: 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
|
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Skin aging assessed by VISIA skin analysis
기간: 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
|
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Skin microbiome
기간: 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
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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
|
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Prosthesis outcome
기간: 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
|
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Urethral Complication Status Assessed by Clinical Examination
기간: 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.
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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
|
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Lower Urinary Tract Symptom Questionnaire
기간: 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
|
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Gut microbiome
기간: 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
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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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: Bettina Winzeler, PD Dr., University Hospital Basel, Department of Endocrinology
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
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연구 등록 날짜
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처음 게시됨 (실제)
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2025년 1월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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마지막으로 확인됨
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추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 2025-00514; kt24Winzeler
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .