Trial document




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  DRKS00015264

Trial Description

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Title

Expression VIII - Individual perception and level of information of patients with a low-grade ovarian carcinoma or a borderline tumor of the ovary

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Trial Acronym

Expression VIII

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URL of the Trial

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Brief Summary in Lay Language

The aim of this anonymous survey is to assess the individual perception and level of information of patients with a low-grade ovarian carcinoma or a borderline tumor of the ovary.

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Brief Summary in Scientific Language

The aim of the present survey is to record the perception and evaluate the informational status of patients with LGSC and BOT of the ovary regarding their disease and therapy. Since only patients with certain histological subtypes of ovarian tumors are involved in the study, it is the first of its kind in a hitherto under-researched area, namely doctor-patient communication and information reception.

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Organizational Data

  •   DRKS00015264
  •   2018/09/12
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  •   yes
  •   Approved
  •   EA2/132/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   ovarian carcinoma
  •   C56 -  Malignant neoplasm of ovary
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Interventions/Observational Groups

  •   Patients with a low-grade ovarian carcinoma will be asked to complete a questionnaire
  •   Patients with borderline tumor of the ovary will be asked to complete a questionnaire
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The aim of the present study is to learn more about the information needs of patients with low-grade serous ovarian cancer and borderline tumor of the ovary with respect to their disease. Patients fill out anonymous questionnaires. The collected data should serve as an indicator for the information status of this patient collective.

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Secondary Outcome

Furthermore, the experience and data collected by this study will be used as a basis for generating new hypotheses and as a basis for discussing possible solutions.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/10/01
  •   300
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

All patients with the diagnosis of all subtypes of a borderline tumor of the ovary and low-grade serous tube, peritoneal and ovarian cancers can be included in the survey. A minimum age of 18 years is required.

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Exclusion Criteria

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Addresses

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    • Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie e.V.
    • c/o Charité Campus Virchow-Klinikum, Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    •   +49 30 450 564 082
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    • Charité - Universitätsmedizin BerlinKlinik für Gynäkologie
    • Ms.  Sara  Alavi 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie
    • Ms.  Lea  Beier 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Tesaro Bio GmbH
    • 80802  München
    • Germany
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Status

  •   Recruiting planned
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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.