Trial document




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  DRKS00017371

Trial Description

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Title

Characteristics related to Assessments of disease, patient and treatment associated with long-term survival in ovarian cancer patients (CAROLIN)-Intergroup study NOGGO/ A-AGO

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Trial Acronym

NOGGO ov45

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of this study is to gather long-term experience from ovarian cancer patients receiving treatment with Niraparib. Patients who live longer than 5 years after diagnosis are designated as long-term survivors in our study. To record the quality of life different questionnaires are used.

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Brief Summary in Scientific Language

In this Non-interventional study (NIS) patients with platin-sensitive relapsed ovarian cancer (OC) will be included who are eligible for Niraparib treatment (treatment decision by physician independently before inclusion of the patients into the study). The Niraparib treatment will be according to SmPC. During the NIS study data will be collected at baseline and every six months for up to seven years follow-up (long term survival) or patient’s death whatever comes first.

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Organizational Data

  •   DRKS00017371
  •   2019/05/22
  •   [---]*
  •   yes
  •   Approved
  •   EA4/184/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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

  •   C56 -  Malignant neoplasm of ovary
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Interventions/Observational Groups

  •   Data about treatment and medical history will be collected from each patient. Approximately every 3 months, medical data is collected and documented. This is done during their routine examination. In addition to the routine, patients should complete questionnaires at baseline, during Niraparib maintenance therapy and at the end of observation.
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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

Identification of disease, patient and treatment factors associated with long term survival. The quality of life is recorded by means of questionnaires, which are completed at each visit (during treatment with Niraparib every 3 months) to the end of treatment (4 weeks after the last dose of Niraparib).

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Secondary Outcome

• Evaluation of therapy management of Niraparib with focus on long term survival (including dose, adverse events, duration of treatment, QoL)
• Identification of Niraparib specific factors associated with long-term survival (<5 vs >5 years)

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • other 
  • Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2019/06/01
  •   300
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

• Female, age at least 18 years
• Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent
• Histologically diagnosed OC (ovarian carcinoma), fallopian tube cancer or primary peritoneal cancer
• For the last chemotherapy course prior to inclusion in the NIS the patient must have achieved a partial (PR) or complete (CR) tumor response
• Patients eligible for Niraparib maintenance therapy according to SmPC
• Patient is able to take oral medications

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Exclusion Criteria

• Known hypersensitivity to the components of the product
• Pregnant or breast-feeding patients

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Addresses

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    • Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie - NOGGO e.V. c/o Charité Universitätsmedizin Berlin Campus Virchow-Klinikum Klinik für Gynäkologie
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    •   [---]*
    •   030868001409
    •   [---]*
    •   [---]*
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    • IKF Klinische Krebsforschung GmbH am Krankenhaus Nordwest
    • Steinbacher Hohl 2-26
    • 60488  Frankfurt am Main
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie - NOGGO e.V. c/o Charité Universitätsmedizin Berlin Campus Virchow-Klinikum Klinik für Gynäkologie
    • Ms.  Anne-Sophie  Gimpel 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie - NOGGO e.V. c/o Charité Universitätsmedizin Berlin Campus Virchow-Klinikum Klinik für Gynäkologie
    • Ms.  Anne-Sophie  Gimpel 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • TESARO Bio Germany GmbH
    • Leopoldstr. 37A
    • 80802  München
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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