Trial document

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DRKS-ID: 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

DRKS-ID: DRKS00022521
Date of Registration in DRKS: 2021/04/14
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 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

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

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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.

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Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Other
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Other
Assignment: Single (group)
Phase: N/A
Off-label Drug use: 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

DE: Germany

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Locations of Recruitment

University Medical Center Sektion für Pädiatrische Endokrinologie und Diabetologie und Klinik für Kinderchirurgie, Lübeck
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 Forschungsinstitut für Frauengesundheit, Tübingen
University Medical Center LMU, Medizinische Klinik und Poliklinik IV, Endokrinologie, München
University Medical Center Zentrum für Reproduktionsmedizin und Andrologie, Münster
University Medical Center Charite, Institut für Experimentelle Pädiatrische Endokrinologie, Berlin
University Medical Center Zentrum für Kinder-, Jugend- und rekonstruktive Urologie, Mannheim
University Medical Center Klinik für Kinderchirurgie, Jena
Medical Center Kliniken Essen-Mitte gGmbH, Klinik für Urologie, Kinderurologie und Urologische Onkologie, Essen

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2021/05/03
Target Sample Size: 640
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: [---]*
Minimum Age: no minimum age
Maximum 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

Primary Sponsor
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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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- Telephone: 0451 500 42810
- Fax: 0451 500 42954
- E-mail: Olaf.Hiort at uksh.de
- URL: http://www.uksh.de
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Contact for Scientific Queries
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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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- Telephone: +49 451 500 42810
- Fax: +49 451 500 42954
- E-mail: Olaf.Hiort at uksh.de
- URL: http://www.uksh.de
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Contact for Public Queries
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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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- Telephone: +49 3101 7612
- Fax: [---]*
- E-mail: u.doehnert at uni-luebeck.de
- URL: http://wwww.uksh.de
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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.)
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- Bundesministerium für Gesundheit
- Unter den Linden 21
- 10117 Berlin
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.bundesgesundheitsministerium.de
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Status

Recruitment Status: Recruiting ongoing
Reason, if "Recruitment stopped after recruiting started" or "Recruiting withdrawn before recruting started": [---]*
Reason, if Reason for Recruiting Stop "Other": [---]*
Study Closing (LPLV): [---]*
Number of Participants in Germany after Recruiting complete: [---]*
Total Number of Participants (all Sites worldwide) after Recruiting complete: [---]*

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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.