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

Organizational Data

DRKS-ID:
DRKS00006072
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2014-04-17
Last update in DRKS:
2014-04-17
Registration type:
Retrospective

Acronym/abbreviation of the study

DSD-Life

URL of the study

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

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.

Brief summary in scientific language

Disorders of Sex Development (DSD)

Health condition or problem studied

ICD10:
Q96 - Turner syndrome
ICD10:
Q97 - Other sex chromosome abnormalities, female phenotype, not elsewhere classified
ICD10:
Q98 - Other sex chromosome abnormalities, male phenotype, not elsewhere classified
ICD10:
Q99 - Other chromosome abnormalities, not elsewhere classified
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 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.

Endpoints

Primary outcome:
Factors that influence the psychosocial adjustment, including HRQoL and the social and psychological well-being for the future clinical care.
Secondary outcome:
Factors that influence metabolism, fertility, surgical results and psychosexual development in order to adjust them in the future clinical care.

Study Design

Purpose:
Treatment
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • France
  • Germany
  • Netherlands
  • Poland
  • Sweden
  • United Kingdom
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Charité - Universitätsmedizin Berlin Berlin

Recruitment period and number of participants

Planned study start date:
2013-10-01
Actual study start date:
2014-01-15
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
1500
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
16 Years
Maximum Age:
no maximum age
Additional 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.

Addresses

Primary Sponsor

Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum Institut für Experimentelle Pädiatrische Endokrinologie
PD Dr. Birgit Köhler
Augustenburger Platz 1
13353 Berlin
Germany
Telephone:
+493045050
Fax:
No Entry
Contact per E-Mail
URL:
http://www.dsd-life.eu/
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum Institut für Experimentelle Pädiatrische Endokrinologie
PD Dr. Birgit Köhler
Augustenburger Platz 1
13353 Berlin
Germany
Telephone:
+493045050
Fax:
No Entry
Contact per E-Mail
URL:
http://www.dsd-life.eu/

Contact for Public Queries

Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum Institut für Experimentelle Pädiatrische Endokrinologie
PD Dr. Birgit Köhler
Augustenburger Platz 1
13353 Berlin
Germany
Telephone:
+493045050
Fax:
No Entry
Contact per E-Mail
URL:
http://www.dsd-life.eu/

Principal Investigator

Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum Institut für Experimentelle Pädiatrische Endokrinologie
PD Dr. Birgit Köhler
Augustenburger Platz 1
13353 Berlin
Germany
Telephone:
+493045050
Fax:
No Entry
Contact per E-Mail
URL:
http://www.dsd-life.eu/

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Europäische Kommission Amt für VeröffentlichungenDirektion "Ressourcen und Logistik"Referat "Ausschreibungen, Verträge und Copyright"Sektion "Copyright und Rechtsangelegenheiten"
2, rue Mercier
2985 Luxembourg
Luxembourg
Telephone:
+352 2929 42210
Fax:
No Entry
Contact per E-Mail
URL:
http://cordis.europa.eu/fp7/home_de.html

Ethics Committee

Address Ethics Committee

Ethikkommission der Charité – Universitätsmedizin Berlin
Charitéplatz 1
10117 Berlin
Germany
Telephone:
(+49)30-450517222
Fax:
(+49)30-450517952
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2013-05-01
Ethics committee number:
EA2/069/13
Vote of the Ethics Committee:
Approved
Date of the vote:
2013-05-16

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry