Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00006072

Trial Description

start of 1:1-Block title

Title

Clinical European study on the outcome of surgical and hormonal therapy and psychological intervention in disorders of sex development (DSD)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

DSD-Life

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.dsd-life.eu/

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

DSD-Life investigates and compares the long-term outcome of not evidence based treatments such as 1. sex assignment, 2. surgery, 3. hormone therapies, 4. psychological interventions in adolescents and adults (≥ 16 years) that are used in patients with various causes of DSD.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Disorders of Sex Development (DSD)

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006072
  •   2014/04/17
  •   [---]*
  •   yes
  •   Approved
  •   EA2/069/13, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Q96 -  Turner syndrome
  •   Q97 -  Other sex chromosome abnormalities, female phenotype, not elsewhere classified
  •   Q98 -  Other sex chromosome abnormalities, male phenotype, not elsewhere classified
  •   Q99 -  Other chromosome abnormalities, not elsewhere classified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Factors that influence the psychosocial adjustment, including HRQoL and the social and psychological well-being for the future clinical care.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Factors that influence metabolism, fertility, surgical results and psychosexual development in order to adjust them in the future clinical care.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   Netherlands
  •   France
  •   Poland
  •   Sweden
  •   United Kingdom
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/01/15
  •   1500
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   16   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

• People with aberrations of the sex chromosomes, XY DSD and DSD YX. • Persons with capacity to consent.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

• People with inadequate cognitive skills for independent answering the questionnaires.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum Institut für Experimentelle Pädiatrische Endokrinologie
    • Ms.  PD Dr.  Birgit  Köhler 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • [---]*
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum Institut für Experimentelle Pädiatrische Endokrinologie
    • Ms.  PD Dr.  Birgit  Köhler 
    • Augustenburger Platz 1
    • 13353   Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum Institut für Experimentelle Pädiatrische Endokrinologie
    • Ms.  PD Dr.  Birgit  Köhler 
    • Augustenburger Platz 1
    • 13353   Berlin
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Europäische Kommission Amt für VeröffentlichungenDirektion "Ressourcen und Logistik"Referat "Ausschreibungen, Verträge und Copyright"Sektion "Copyright und Rechtsangelegenheiten"
    • CORDIS Help Desk 
    • 2, rue Mercier
    • 2985   Luxembourg
    • Luxembourg
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.