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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00006072 |
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Date of registration:
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17/04/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical European study on the outcome of surgical and hormonal therapy and psychological intervention in disorders of sex development (DSD)
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Scientific title:
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Clinical European study on the outcome of surgical and hormonal therapy and psychological intervention in disorders of sex development (DSD) - DSD-Life |
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Date of first enrolment:
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15/01/2014 |
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Target sample size:
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1500 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00006072 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment
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Phase:
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Countries of recruitment
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France
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Germany
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Netherlands
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Poland
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Sweden
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United Kingdom
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Contacts
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Name:
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Birgit
Köhler |
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Address:
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Augustenburger Platz 1
13353
Berlin
Germany |
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Telephone:
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+493045050 |
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Email:
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eustudie-koehler@charite.de |
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Affiliation:
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Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum Institut für Experimentelle Pädiatrische Endokrinologie |
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Name:
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Birgit
Köhler |
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Address:
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Augustenburger Platz 1
13353
Berlin
Germany |
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Telephone:
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+493045050 |
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Email:
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eustudie-koehler@charite.de |
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Affiliation:
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Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum Institut für Experimentelle Pädiatrische Endokrinologie |
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Key inclusion & exclusion criteria
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Inclusion criteria: • People with aberrations of the sex chromosomes, XY DSD and DSD YX. • Persons with capacity to consent.
Exclusion criteria: • People with inadequate cognitive skills for independent answering the questionnaires.
Age minimum:
16 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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Q96
Q97
Q98
Q99
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Turner syndrome
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Other chromosome abnormalities, not elsewhere classified
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Other sex chromosome abnormalities, female phenotype, not elsewhere classified
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Other sex chromosome abnormalities, male phenotype, not elsewhere classified
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Intervention(s)
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Group 1: Data is collected about the group of patients/subjects with disorders of sex development. This is done by questionnaires and physical examinations about 1 Gender assignment, 2 Surgical treatment, 3 Hormone therapy and 4 psychological interventions.
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Primary Outcome(s)
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Factors that influence the psychosocial adjustment, including HRQoL and the social and psychological well-being for the future clinical care.
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Secondary Outcome(s)
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Factors that influence metabolism, fertility, surgical results and psychosexual development in order to adjust them in the future clinical care.
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Source(s) of Monetary Support
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Europäische Kommission Amt für VeröffentlichungenDirektion "Ressourcen und Logistik"Referat "Ausschreibungen, Verträge und Copyright"Sektion "Copyright und Rechtsangelegenheiten"
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Ethics review
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Status: Approved
Approval date: 16/05/2013
Contact:
ethikkommission@charite.de
Ethikkommission der Charité – Universitätsmedizin Berlin
(+49)30-450517222
ethikkommission@charite.de
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