OSCA - Olaparib Standard of CAre Study

Study Overview
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Brief Summary
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This study will be carried out as a retrospective, non-interventional observational review of medical records for patients in multiple countries with platinum-sensitive recurrent serous ovarian cancer. The objectives are to describe in a real-world population, treatment patterns, BRCA mutation testing and results, overall survival, health care utilization and also to estimate rates of selected treatment- and/or disease-related side effects

Official Title
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Real-World Treatment Patterns, BRCA Testing Practices, Outcomes, and Health Care Utilization in Platinum-Sensitive Recurrent Serous Ovarian Cancer: A Multi-Country Retrospective Study

Conditions
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Platinum-sensitive Recurrent Serous Ovarian Cancer

Intervention / Treatment
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* Other: Data Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First determined to have platinum-sensitive recurrent serous ovarian cancer between January 1, 2009, and December 31, 2013 (study entry period), as defined by no evidence of disease progression for at least 6 months after completion of a first-line platinum-based chemotherapy regimen; the first date of platinum-sensitive recurrence between January 1, 2009 and December 31, 2013 will define the study index date. At least 18 years of age on the index date. Fully documented medical history related to the patient's ovarian cancer treatment beginning with initial diagnosis of serous ovarian cancer. Patients can be either alive or deceased at the time of medical record abstraction. Exclusion Criteria: 1. Ever taken an investigational product as part of an interventional clinical trial for ovarian cancer.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Serous ovarian cancer:<br>Women with platinum-sensitive recurrent serous ovarian cancer | Other: Data Collection<br>* Colleciton of data from medical records only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best response to therapy and date of response for each subsequent therapy line post-index | Response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) Criteria on which physicians determined therapy response also will be captured (e.g., symptoms, radiological and/or other imaging findings, CA-125 levels, physical exam, or other criteria). | Data will be collected retrospectively from medical records | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival, by therapy line | Defined as time from initiation of the therapy line (including the required first-line platinum-based chemotherapy) until the earliest of progression, death, or end of follow-up (for censored observations) Criteria on which physicians determined progression also will be captured (e.g., symptoms, radiological and/or other imaging findings, CA-125 levels, physical exam, or other criteria) | Data will be collected retrospectively from medical records | 
| Overall survival, calculated from various time points | From first diagnosis of ovarian cancer until death or end of follow-up, whichever is earliest From initiation of the required first-line platinum-based chemotherapy regimen until death or end of follow-up, whichever is earliest From the index date (first determination of platinum-sensitive recurrence) until death or end of follow-up, whichever is earliest From initiation of each subsequent, post-index therapy line until death or end of follow-up, whichever is earliest | Data will be collected retrospectively from medical records | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PARP, Olaparib, women, platinum sensitive, recurrent, serous, ovarian cancer, BRCA