C-PATROL - Non-interventional Study (NIS) to Collect Clinical and Patient Reported Outcome Data in an Olaparib Treated BRCAm+ PSR Ovarian Cancer Population
NCT ID: NCT02503436
Last Updated: 2023-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
276 participants
OBSERVATIONAL
2015-10-28
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Women aged ≥ 18 years
* Patients with platinum sensitive relapsed high grade epithelial ovarian cancers (including primary peritoneal and/or fallopian tube cancer). (Platinum sensitive disease is defined as disease progression ≥6 months after completion of their last dose of platinum based chemotherapy. Patients must be currently in response to platinum-based chemotherapy. For the last chemotherapy course immediately prior to enrolment on the study, patients must be, in the opinion of the investigator, in response (partial or complete), following completion of this chemotherapy course.
* Documented BRCA mutations (germline and/or somatic mutation in BRCA1 (Breast Cancer gene 1) and/or BRCA2 (Breast Cancer gene 2) that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function))
* Patients should be in line with the specifications mentioned in the German LYNPARZA (olaparib) SmPC (Summary Product Characteristics) for hard capsules or tablets.
* Patients are able to read and understand German, English, Turkish or Arabic
Exclusion Criteria
* Patients who have started olaparib monotherapy for more than 14 days before giving their informed consent
* Pregnancy or breast feeding
18 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Amberg, , Germany
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Aschaffenburg, , Germany
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Augsburg, , Germany
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Bad Homburg, , Germany
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Berlin, , Germany
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Bonn, , Germany
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Bottrop, , Germany
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Brandenburg, , Germany
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Braunschweig, , Germany
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Bremen, , Germany
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Chemnitz, , Germany
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Coburg, , Germany
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Cologne, , Germany
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Donauwörth, , Germany
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Dortmund, , Germany
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Dresden, , Germany
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Duisburg, , Germany
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Düsseldorf, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Esslingen am Neckar, , Germany
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Eutin, , Germany
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Frankfurt, , Germany
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Freiburg im Breisgau, , Germany
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Fürstenwalde, , Germany
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Georgsmarienhütte, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Heidenheim, , Germany
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Hildesheim, , Germany
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Homburg/Saar, , Germany
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Jena, , Germany
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Karlsruhe, , Germany
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Kassel, , Germany
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Kempten, , Germany
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Kiel, , Germany
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Krefeld, , Germany
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Kulmbach, , Germany
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Landshut, , Germany
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Lübeck, , Germany
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Mainz, , Germany
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Mannheim, , Germany
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Mönchengladbach, , Germany
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Mutlangen, , Germany
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München, , Germany
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Münster, , Germany
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Nuremberg, , Germany
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Oberhausen, , Germany
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Osnabrück, , Germany
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Paderborn, , Germany
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Plauen, , Germany
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Regensburg, , Germany
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Rosenheim, , Germany
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Rostock, , Germany
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Saarbrücken, , Germany
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Schwerin, , Germany
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Singen, , Germany
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Solingen, , Germany
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Stralsund, , Germany
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Stuttgart, , Germany
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Traunstein, , Germany
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Troisdorf, , Germany
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Tübingen, , Germany
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Wiesbaden, , Germany
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Wolfsburg, , Germany
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Würzburg, , Germany
Countries
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Related Links
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Other Identifiers
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D0816R00009
Identifier Type: -
Identifier Source: org_study_id