Trial document





This trial has been registered retrospectively.
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  DRKS00016576

Trial Description

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Title

Frankfurt Pediatric Fertility Registry

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Within the registry we want to documentate the fertility counseling of pediatric oncological patients and pediatric patients facing a stem cell transplantation. Data of disease, mode of therapy and risk of gonadotoxic damage will be documented as well as the performance of fertility preserving procedures.

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Brief Summary in Scientific Language

Pediatric patients with oncological disesases or facing a stem cell transplantation for either malignant or non-malignant dieseases who are counseled concerning fertility issues due to their disease and treamtent can take part in this registry. After obtaining informed consent the registry documents the personal and medical data of the pediatric patients as well as the performance and results of the fertility counseling. Data will be documented concerning performance of fertility preserving procedures like sperm cryopreservation, ovarian or oocyte cryopreservation, the side-effects of those procedures and the follow up of the patients after therapy.

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Organizational Data

  •   DRKS00016576
  •   2019/02/08
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  •   yes
  •   Approved
  •   239/17, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

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Health Condition or Problem studied

  •   C00-D48 -  Neoplasms
  •   D50-D90 -  Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
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Interventions/Observational Groups

  •   Data aquisition after written informed consent. Patient identifying data like name, date of birth, gender, address are taken. disease related data like disease, planed therapy, gonadotoxic risk are documented. Medical data like pubertal development, hormone status as well as date and recommendation of fertility counseling are taken. Documentation of fertility preserving procedures, place and date of tissue banking and sideeffects of the procedures are documented.
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Characteristics

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

collection of descriptive data concerning fertility counseling and performance of fertility preserving procedures

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Secondary Outcome

follow up of patients concerning developement of fertility

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/05/01
  •   800
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   0   Years
  •   25   Years
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Additional Inclusion Criteria

pediatric oncological disease or pediatric stem cell transplantation

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Exclusion Criteria

no informed consent

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Addresses

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    • Uniklinik FrankfurtKlinik für Kinder und Jugendmedizin
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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    • Klinik für Kinder- und Jugendmedizin
    • Ms.  Dr.  Anke  Barnbrock 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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    • Klinik für Kinder- und Jugendmedizin
    • Ms.  Dr.  Anke  Barnbrock 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik FrankfurtKlinik für Kinder und Jugendmedizin
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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