Standardized healthcare-center-centered care of DSD over the life span
Organizational Data
- DRKS-ID:
- DRKS00022521
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2021-04-14
- Last update in DRKS:
- 2023-12-05
- Registration type:
- Prospective
Acronym/abbreviation of the study
DSDCare
URL of the study
Brief summary in lay language
Human sexual development is determined by a complex interaction of genes, hormones and environment. As a result, some people can have both male and female characteristics, which are called “Differences of sex development (DSD)”. They are rare conditions and should be cared for in specialized centres where different medical and psychosocial professions can offer holistic care and peer support. In Germany a guideline dealing with care for people with DSD has been published in 2006. The project aims to improve care for people with DSD over the lifespan. Ten specialized centres and two patient organisations will be working together in developing precise recommendations for clinical investigations and therapies and translating them into daily routine. They will offer training schools and peer support to patients in order to empower them to participate in treatment decisions. At the same time an operational help desk and continuing education for external health care providers will be offered in order to facilitate access to special care. The achievement of these goals will be evaluated by means of a registry and patient interviews. The latter will focus on patient satisfaction and quality of life.
Brief summary in scientific language
Differences of sex development (DSD) refer to a variety of congenital conditions affecting genetic, endocrine and clinical factors of sexual development and differentiation. Depending on cause, characteristics and time of diagnosis different aspects of care have to be addressed. These include handling of diagnosis, psychosocial support, queries concerning puberty, sexuality and reproduction as well as therapeutic options as hormone replacement or genital surgery. The project aims to improve structural and process quality of medical and psychosocial care for people with DSD over the lifespan. This will be achieved by specifying and implementing the national guideline “Differences of Sex Development” established in 2016 and optimizing it based on the recommendations of the German Ethics Council and the German Medical Association. Multi-professional and interdisciplinary collaboration will improve quality of care in four EU accredited centres in five locations, two regionally approved centres, three institutions with specialised surgical expertise, equally involving two patient organizations. Establishment of an operational help desk and certified continuing education will allow for collaboration of DSD centres and peripheral health care providers. Qualified peer support and training courses will be offered to people with DSD in order to enhance participation in care. Quality indicators will be developed from the national guideline, international recommendations and qualitative interviews and will provide for monitoring and evaluation of structural, process and outcome quality, a nationwide benchmarking and harmonization of care. Project evaluation will include further patient- and provider-centred outcome parameters.
Health condition or problem studied
- ICD10:
- E25.0 - Congenital adrenogenital disorders associated with enzyme deficiency
- ICD10:
- E28.3 - Primary ovarian failure
- ICD10:
- E29.1 - Testicular hypofunction
- ICD10:
- E29.9 - Testicular dysfunction, unspecified
- ICD10:
- E34.5 - Androgen resistance syndrome
- ICD10:
- K43.6 - Other and unspecified ventral hernia with obstruction without gangrene
- ICD10:
- Q51.8 - Other congenital malformations of uterus and cervix
- ICD10:
- Q56 - Indeterminate sex and pseudohermaphroditism
- ICD10:
- Q55.8 - Other specified congenital malformations of male genital organs
- ICD10:
- Q64.1 - Exstrophy of urinary bladder
- ICD10:
- Q87.1 - Congenital malformation syndromes predominantly associated with short stature
- ICD10:
- Q87.8 - Other specified congenital malformation syndromes, not elsewhere classified
- ICD10:
- Q96 - Turner syndrome
- ICD10:
- Q97.3 - Female with 46,XY karyotype
- ICD10:
- Q98 - Other sex chromosome abnormalities, male phenotype, not elsewhere classified
- ICD10:
- Q99.0 - Chimera 46,XX/46,XY
- ICD10:
- Q99.1 - 46,XX true hermaphrodite
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- People with differences/disorders of sex development (DSD) according to the Chicago classification 2005; inclusion into clinical registry and completion of standardised questionnaires capturing socio-demographic items, and measuring quality of life and satisfaction with care, immediately/ 6 and 12 months after visit to DSD center.
Endpoints
- Primary outcome:
- Structural and process quality of care
- Secondary outcome:
- Outcome quality
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- Prospective
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- Patient Registry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Klinik für allgemeine Kinder- und Jugendmedizin Kiel
- University medical center Sektion Pädiatrische Endokrinologie und Klinik für Allgemein- und Viszeralchirurgie, Sektion Kinderchirurgie Ulm
- University medical center Zentrum für Kinder-, Jugend- und rekonstruktive Urologie Mannheim
- University medical center Charite, Institut für Experimentelle Pädiatrische Endokrinologie Berlin
- Medical center Kliniken Essen-Mitte gGmbH, Klinik für Urologie, Kinderurologie und Urologische Onkologie Essen
- University medical center Sektion für Pädiatrische Endokrinologie und Diabetologie und Klinik für Kinderchirurgie Lübeck
- University medical center Zentrum für Reproduktionsmedizin und Andrologie Münster
- University medical center LMU, Medizinische Klinik und Poliklinik IV, Endokrinologie München
- University medical center Forschungsinstitut für Frauengesundheit Tübingen
- University medical center Klinik für Kinderchirurgie Jena
Recruitment period and number of participants
- Planned study start date:
- 2021-05-01
- Actual study start date:
- 2021-05-03
- Planned study completion date:
- 2023-06-30
- Actual Study Completion Date:
- 2023-06-30
- Target Sample Size:
- 640
- Final Sample Size:
- 596
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- no minimum age
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Diagnosis of DSD according to Chicago Classification 2005 OR - overt genital ambiguity - apparent female genitalia with an enlarged clitoris, posterior labial fusion, or an inguinal/labial mass - apparent male genitalia with bilateral undescended testes, micropenis, isolated perineal hypospadias, or mild hypospadias with undescended testes - discordance between genital appearance and a prenatal karyotype - female phenotype with pubertal virilization and/or primary amenorrhea and/or no thelarche - male phenotype with pubertal hypovirilization AND written consent to participate in the study
Exclusion Criteria
- acquired hypogonadotropic hypogonadism - no written consent
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Schleswig-HolsteinKlinik für Kinder- und JugendmedizinSektion Pädiatrische Endokrinologie und DiabetologieProf. Dr. med. Olaf HiortRatzeburger Allee 16023538 LübeckGermany
- Telephone:
- 0451 500 42810
- Fax:
- 0451 500 42954
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uksh.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Schleswig-HolsteinKlinik für Kinder- und JugendmedizinSektion für Pädiatrische Endokrinologie und DiabetologieProf. Dr. med. Olaf HiortRatzeburger Allee 16023538 LübeckGermany
- Telephone:
- +49 451 500 42810
- Fax:
- +49 451 500 42954
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uksh.de
Contact for Public Queries
- Address:
- Universitätsklinikum Schleswig-HolsteinKlinik für Kinder- und JugendmedizinSektion für Pädiatrische Endokrinologie und DiabetologieDr. med. Ulla DöhnertRatzeburger Allee 16023538 LübeckGermany
- Telephone:
- +49 3101 7612
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://wwww.uksh.de
Principal Investigator
- Address:
- Universitätsklinikum Schleswig-HolsteinKlinik für Kinder- und JugendmedizinSektion für Pädiatrische Endokrinologie und DiabetologieProf. Dr. med. Olaf HiortRatzeburger Allee 16023538 LübeckGermany
- Telephone:
- +49 451 500 42810
- Fax:
- +49 451 500 42954
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uksh.de
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.)
- Address:
- Bundesministerium für GesundheitUnter den Linden 2110117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bundesgesundheitsministerium.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Med. Fakultät der Universität zu LübeckRatzeburger Allee 16023538 LübeckGermany
- Telephone:
- +49-451-5004639
- Fax:
- +49-451-5003026
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-09-03
- Ethics committee number:
- AZ 20-322
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-09-09
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- All of the individual participant data collected during the trial, after deidentification, as well as the study protocol, informed consent form, statistical analysis plan and analytical code will be available for two years following publication. Written methodologically sound proposals should be directed to Olaf.Hiort@uksh.de. All proposals will be reviewed by the governance board of the project.
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