Trial document




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  DRKS00022521

Trial Description

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Title

Standardized healthcare-center-centered care of DSD over the life span

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Trial Acronym

DSDCare

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URL of the Trial

http://www.dsdcare.de

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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.

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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.

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Do you plan to share individual participant data with other researchers?

Yes

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Description 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.

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Organizational Data

  •   DRKS00022521
  •   2021/04/14
  •   [---]*
  •   yes
  •   Approved
  •   AZ 20-322, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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Health Condition or Problem studied

  •   E25.0 -  Congenital adrenogenital disorders associated with enzyme deficiency
  •   E28.3 -  Primary ovarian failure
  •   E29.1 -  Testicular hypofunction
  •   E29.9 -  Testicular dysfunction, unspecified
  •   E34.5 -  Androgen resistance syndrome
  •   K43.6 -  Other and unspecified ventral hernia with obstruction without gangrene
  •   Q51.8 -  Other congenital malformations of uterus and cervix
  •   Q56 -  Indeterminate sex and pseudohermaphroditism
  •   Q55.8 -  Other specified congenital malformations of male genital organs
  •   Q64.1 -  Exstrophy of urinary bladder
  •   Q87.1 -  Congenital malformation syndromes predominantly associated with short stature
  •   Q87.8 -  Other specified congenital malformation syndromes, not elsewhere classified
  •   Q96 -  Turner syndrome
  •   Q97.3 -  Female with 46,XY karyotype
  •   Q98 -  Other sex chromosome abnormalities, male phenotype, not elsewhere classified
  •   Q99.0 -  Chimera 46,XX/46,XY
  •   Q99.1 -  46,XX true hermaphrodite
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Interventions/Observational Groups

  •   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.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Structural and process quality of care

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Secondary Outcome

Outcome quality

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2021/05/03
  •   640
  •   Multicenter trial
  •   National
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Inclusion Criteria

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  •   no minimum age
  •   no maximum age
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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

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Exclusion Criteria

- acquired hypogonadotropic hypogonadism
- no written consent

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Addresses

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    • Universitätsklinikum Schleswig-HolsteinKlinik für Kinder- und JugendmedizinSektion Pädiatrische Endokrinologie und Diabetologie
    • Mr.  Prof. Dr. med.  Olaf  Hiort 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Universitätsklinikum Schleswig-HolsteinKlinik für Kinder- und JugendmedizinSektion für Pädiatrische Endokrinologie und Diabetologie
    • Mr.  Prof. Dr. med.  Olaf  Hiort 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Universitätsklinikum Schleswig-HolsteinKlinik für Kinder- und JugendmedizinSektion für Pädiatrische Endokrinologie und Diabetologie
    • Ms.  Dr. med.  Ulla  Döhnert 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Gesundheit
    • Unter den Linden 21
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.