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The main objective of the proposed non-interventional study is to obtain real-world effectiveness, safety and treatment patterns data of patients with BRCAm+ (Breast Cancer Gene(s) mutation positive) platinum sensitive relapsed (PSR) ovarian cancer in German hospitals and outpatient practices treated with olaparib.
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| Measure | Description | Time Frame |
|---|---|---|
| To assess clinical effectiveness of olaparib maintenance monotherapy by assessment of progression free survival (PFS) in patients with BRCAm+ ovarian cancer. Methods and time intervals for tumor assessment depend on the investigator's decision. | Date of first documented dose of olaparib to the date of progression (as judged by the investigator) or death (of any cause) whichever occurred before, assessed approximately up to 84 months |
| Measure | Description | Time Frame |
|---|---|---|
| To collect and explore real-life data on patient outcomes in terms of Overall Survival (OS) | Date of first documented dose of olaparib to death of any cause, assessed approximately up to 84 months | |
| Time to first subsequent therapy (TFST) | Date of first documented dose of olaparib to date of first administration of first subsequent therapy or death if this occurs before commencement of first subsequent treatment, assessed approximately up to 84 months |
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Inclusion Criteria:
Exclusion Criteria:
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300 patients in 80 sites (approx. 40 hospitals and 40 outpatient practices) in Germany. Each site should enrol 2-30 patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Amberg | Germany | ||||
| Research Site |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| Progression-free survival 2 (PFS2) | Date of first administration of first subsequent therapy to date of progression as assessed by the investigator or death, assessed approximately up to 84 months |
| Time to second subsequent therapy (TSST) | Date of first documented dose of olaparib to date of first administration of second subsequent therapy or death if this occurs before commencement of second subsequent treatment, assessed approximately up to 84 months |
| Time to discontinuation of olaparib monotherapy (TDO) | Date of first documented dose of olaparib montherapy to date of last documented dose of olaparib monotherapy or death whichever occurred before, assessed approximately up to 84 months |
| Assessment of health-related quality of life (HRQoL) in patients participating in the study. | Health related quality of life (HRQoL): Assessment of general cancer-associated and specific ovarian cancer associated parameters by use of standardized HRQoL questionnaires:
| Date of first visit to last visit. HRQoL are collected every 3 months up to 84 months |
| Safety of Olaparib: collection of Adverse Events (AE) | Type and frequeny of adverse event (AE), intensity, causal relationship to olaparib, outcome, seriousness, management of adverse event | Date of first documented dose of Olaparib to last visit, assessed approximately up to 84 months |
| Aschaffenburg |
| Germany |
| Research Site | Augsburg | Germany |
| Research Site | Bad Homburg | Germany |
| Research Site | Berlin | Germany |
| Research Site | Bonn | Germany |
| Research Site | Bottrop | Germany |
| Research Site | Brandenburg an der Havel | Germany |
| Research Site | Braunschweig | Germany |
| Research Site | Bremen | Germany |
| Research Site | Chemnitz | Germany |
| Research Site | Coburg | Germany |
| Research Site | Cologne | Germany |
| Research Site | Donauwörth | Germany |
| Research Site | Dortmund | Germany |
| Research Site | Dresden | Germany |
| Research Site | Duisburg | Germany |
| Research Site | Düsseldorf | Germany |
| Research Site | Erlangen | Germany |
| Research Site | Essen | Germany |
| Research Site | Esslingen am Neckar | Germany |
| Research Site | Eutin | Germany |
| Research Site | Frankfurt | Germany |
| Research Site | Freiburg im Breisgau | Germany |
| Research Site | Fürstenwalde | Germany |
| Research Site | Georgsmarienhütte | Germany |
| Research Site | Halle | Germany |
| Research Site | Hamburg | Germany |
| Research Site | Hanover | Germany |
| Research Site | Heidelberg | Germany |
| Research Site | Heidenheim | Germany |
| Research Site | Hildesheim | Germany |
| Research Site | Homburg/Saar | Germany |
| Research Site | Jena | Germany |
| Research Site | Karlsruhe | Germany |
| Research Site | Kassel | Germany |
| Research Site | Kempten | Germany |
| Research Site | Kiel | Germany |
| Research Site | Krefeld | Germany |
| Research Site | Kulmbach | Germany |
| Research Site | Landshut | Germany |
| Research Site | Lübeck | Germany |
| Research Site | Mainz | Germany |
| Research Site | Mannheim | Germany |
| Research Site | Mönchengladbach | Germany |
| Research Site | Mutlangen | Germany |
| Research Site | München | Germany |
| Research Site | Münster | Germany |
| Research Site | Nuremberg | Germany |
| Research Site | Oberhausen | Germany |
| Research Site | Osnabrück | Germany |
| Research Site | Paderborn | Germany |
| Research Site | Plauen | Germany |
| Research Site | Regensburg | Germany |
| Research Site | Rosenheim | Germany |
| Research Site | Rostock | Germany |
| Research Site | Saarbrücken | Germany |
| Research Site | Schwerin | Germany |
| Research Site | Singen | Germany |
| Research Site | Solingen | Germany |
| Research Site | Stralsund | Germany |
| Research Site | Stuttgart | Germany |
| Research Site | Traunstein | Germany |
| Research Site | Troisdorf | Germany |
| Research Site | Tübingen | Germany |
| Research Site | Wiesbaden | Germany |
| Research Site | Wolfsburg | Germany |
| Research Site | Würzburg | Germany |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| C563980 | Fanconi Anemia, Complementation Group D1 |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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