Trial document




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  DRKS00009240

Trial Description

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Title

German prospective register study for detecting the treatment of gynecological sarcomas in clinical routine

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Trial Acronym

REGSA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Sarcomas are rare tumors and even more rarely affect the gynecological organs such as the uterus and ovaries. In Germany about 200 to 300 women fall ill every year at a sarcoma of the uterus.
Although carcinosarcomas account for <5% of all uterine malignancies, they are associated with >15 % of uterine cancer-associated deaths. This aggressive behavior along with its unique histological appearance represents a diagnostic challenge.
But an effective targeted therapy requires in advance an accurate diagnosis of the tumor subgroups by immunohistochemical and molecular techniques.
It is always important to plan the detailed treatment as an overall concept which includes the operating procedures, the systematic analysis of the tumor tissue, but also the discussion of possible chemo- and hormonal therapy respectively radiation or targeted cancer therapies, which is adapted to individual risk. At this the therapy regimes differs substantially from different tumor types and individual situation.
The introduction of a gynecological sarcoma register is an important precondition for the improvement of the diagnostics and treatment of sarcomas and treatment of them. This register is the possibility to have more information on the incidence of individual sarcoma subtypes and their treatment to generate the standard of care.

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Brief Summary in Scientific Language

Sarcomas are rare tumors and even more rarely affect the gynecological organs such as the uterus and ovaries. In Germany about 200 to 300 women fall ill every year at a sarcoma of the uterus.
Although carcinosarcomas account for <5% of all uterine malignancies, they are associated with >15 % of uterine cancer-associated deaths. This aggressive behavior along with its unique histological appearance represents a diagnostic challenge.
But an effective targeted therapy requires in advance an accurate diagnosis of the tumor subgroups by immunohistochemical and molecular techniques.
It is always important to plan the detailed treatment as an overall concept which includes the operating procedures, the systematic analysis of the tumor tissue, but also the discussion of possible chemo- and hormonal therapy respectively radiation or targeted cancer therapies, which is adapted to individual risk. At this the therapy regimes differs substantially from different tumor types and individual situation. A survey among 374 gynaecologists could show that there is a great uncertainty concerning the standard therapy of uterine sarcomas.
The introduction of a gynecological sarcoma register is an important precondition for the improvement of the diagnostics and treatment of sarcomas and treatment of them. This register is the possibility to have more information on the incidence of individual sarcoma subtypes and their treatment to generate the standard of care.

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Organizational Data

  •   DRKS00009240
  •   2015/08/18
  •   [---]*
  •   yes
  •   Approved
  •   EA2/041/15, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Leimyosarcom
  •   endometrial stromal sarcoma
  •   undifferenciated endometrial stroma sarcom
  •   C49 -  Malignant neoplasm of other connective and soft tissue
  •   C54 -  Malignant neoplasm of corpus uteri
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Interventions/Observational Groups

  •   documentation of the current treatment of gynaecological sarcoma and their treatment success after 12 month regardless of type of therapy and line of therapy
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Characteristics

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

1. Complete detection of gynecological sarcomas in Germany
2. Registration and safeguarding of diagnostic and therapeutic standards at different subtypes

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Secondary Outcome

1. Basis for innovative new therapeutic concepts

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Countries of Recruitment

  •   Germany
  •   Austria
  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2015/10/02
  •   120
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. patients with gynecological sarcomas regardless of therapy and treatment line
2. Informed Consent

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Exclusion Criteria

1. Patients with non-gynecologic sarcomas
2. Lack of informed consent

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Addresses

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    • NOGGO e.V. c/o Universitätsmedizin BerlinKlinik für Gynäkologie
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    •   [---]*
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    • Charité Universitätsmedizin BerlinCampus VirchowKlinik für Gynäkologie
    • Mr.  Prof.  Jalid  Sehouli 
    • Augustenburger Straße 1
    • 13353  Berlin
    • Germany
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    • NOGGO e.V. c/o Universitätsmedizin BerlinKlinik für Gynäkologie
    • Ms.  Dr.   Maren   Keller 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • NOGGO e.V. c/o Universitätsmedizin BerlinKlinik für Gynäkologie
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    •   [---]*
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    • PharmaMar
    • Uhlandstraße 14
    • 10623  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.