Platinum-sensitive Recurrent Serous Ovarian Cancer Clinical Trial
— OSCAOfficial title:
Real-World Treatment Patterns, BRCA Testing Practices, Outcomes, and Health Care Utilization in Platinum-Sensitive Recurrent Serous Ovarian Cancer: A Multi-Country Retrospective Study
| Verified date | February 2017 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 2123 |
| Est. completion date | April 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. 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. 2. At least 18 years of age on the index date. 3. Fully documented medical history related to the patient's ovarian cancer treatment beginning with initial diagnosis of serous ovarian cancer. 4. 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Research Site | Ballarat | |
| Australia | Research Site | Birtinya | |
| Australia | Research Site | Campbelltown | |
| Australia | Research Site | East Melbourne | |
| Australia | Research Site | Mandurah, Western Australia | |
| Australia | Research Site | South Brisbane | |
| Australia | Research Site | St Leonards | |
| Australia | Research Site | Victoria | |
| Australia | Research Site | Waratah | |
| Belgium | Research Site | Edegem | |
| Belgium | Research Site | Namur | |
| Belgium | Research Site | Sint-Niklaas | |
| Canada | Research Site | Alberta | |
| Canada | Research Site | Charlottetown | |
| Canada | Research Site | Mississauga | |
| Canada | Research Site | Montreal | |
| Canada | Research Site | Ottawa | |
| Canada | Research Site | Red Deer | |
| Canada | Research Site | Toronto | |
| Canada | Research Site | Vancouver | |
| France | Research Site | Aix En Provence | |
| France | Research Site | Ajaccio | |
| France | Research Site | Auxerre | |
| France | Research Site | Besancon | |
| France | Research Site | Beziers | |
| France | Research Site | Bordeaux | |
| France | Research Site | Bourg-en-bresse | |
| France | Research Site | Brest | |
| France | Research Site | Caen | |
| France | Research Site | Chambery | |
| France | Research Site | Colombes | |
| France | Research Site | Grenoble | |
| France | Research Site | Libourne Cedex | |
| France | Research Site | Longjumeau | |
| France | Research Site | Lyon | |
| France | Research Site | Marseille | |
| France | Research Site | Mont de Marsan | |
| France | Research Site | Montbeliard | |
| France | Research Site | Montpellier | |
| France | Research Site | Mulhouse | |
| France | Research Site | Nantes | |
| France | Research Site | Narbonne | |
| France | Research Site | Quimper | |
| France | Research Site | Rennes Cedex | |
| France | Research Site | St Pierre Du Mont | |
| France | Research Site | Strasbourg | |
| France | Research Site | Toulouse | |
| France | Research Site | Tours Cedex 9 | |
| France | Research Site | Villejuif | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Bonn Bad Godesberg | |
| Germany | Research Site | Chemnitz | |
| Germany | Research Site | Dusseldorf | |
| Germany | Research Site | Erlangen | |
| Germany | Research Site | Essen | |
| Germany | Research Site | Frankfurt | |
| Germany | Research Site | Frankfurt am Main | |
| Germany | Research Site | Hagen | |
| Germany | Research Site | Hamburg | |
| Germany | Research Site | Heidelberg | |
| Germany | Research Site | Heilbronn | |
| Germany | Research Site | Karlsruhe | |
| Germany | Research Site | Kiel | |
| Germany | Research Site | Koln | |
| Germany | Research Site | Kothen | |
| Germany | Research Site | Leverkusen | |
| Germany | Research Site | Munchen | |
| Germany | Research Site | Nurnberg | |
| Germany | Research Site | Osnabruck | |
| Germany | Research Site | Passau | |
| Germany | Research Site | Ratingen | |
| Germany | Research Site | Saarlouis | |
| Germany | Research Site | Stuttgart | |
| Germany | Research Site | Ulm | |
| Germany | Research Site | Velbert | |
| Germany | Research Site | Wetzlar | |
| Israel | Research Site | Afula | |
| Israel | Research Site | Haifa | |
| Israel | Research Site | Jerusalem | |
| Israel | Research Site | Netanya | |
| Israel | Research Site | Petah Tikva | |
| Israel | Research Site | Rehovot | |
| Israel | Research Site | St. Holon | |
| Israel | Research Site | Tel Aviv | |
| Israel | Research Site | Tel Hashomer | |
| Italy | Research Site | Alessandria | |
| Italy | Research Site | Aosta | |
| Italy | Research Site | Ariano Irpino | |
| Italy | Research Site | Avellino | |
| Italy | Research Site | Bari | |
| Italy | Research Site | Brescia | |
| Italy | Research Site | Brindisi | |
| Italy | Research Site | Caltagirone | |
| Italy | Research Site | Candiolo | |
| Italy | Research Site | Carbonia | |
| Italy | Research Site | Castelfranco Veneto | |
| Italy | Research Site | Castellana Grotte | |
| Italy | Research Site | Castellaneta | |
| Italy | Research Site | Catania | |
| Italy | Research Site | Figline Valdarno | |
| Italy | Research Site | Franca | |
| Italy | Research Site | Genova | |
| Italy | Research Site | Gorizia | |
| Italy | Research Site | Gravina di Catania | |
| Italy | Research Site | Ivrea | |
| Italy | Research Site | Latina | |
| Italy | Research Site | Latisana | |
| Italy | Research Site | Lecce | |
| Italy | Research Site | Lido di Ostia | |
| Italy | Research Site | Manduria | |
| Italy | Research Site | Manerbi | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Monselice | |
| Italy | Research Site | Monserrato | |
| Italy | Research Site | Monza | |
| Italy | Research Site | Napoli | |
| Italy | Research Site | Orbassano | |
| Italy | Research Site | Padova | |
| Italy | Research Site | Palmanova | |
| Italy | Research Site | Ponte a Niccheri | |
| Italy | Research Site | Portogruaro | |
| Italy | Research Site | Reggio Calabria | |
| Italy | Research Site | Rieti | |
| Italy | Research Site | Rionero in Vulture | |
| Italy | Research Site | Roma | |
| Italy | Research Site | San Gavino Monreale | |
| Italy | Research Site | Santorso VI | |
| Italy | Research Site | Seriate | |
| Italy | Research Site | Sesto San Giovanni | |
| Italy | Research Site | Solofra | |
| Italy | Research Site | Taranto | |
| Italy | Research Site | Torino | |
| Italy | Research Site | Trieste | |
| Korea, Republic of | Research Site | Gyeonggi-do | |
| Korea, Republic of | Research Site | Seoul | |
| Netherlands | Research Site | Dordrecht | |
| Netherlands | Research Site | Enschede | |
| Netherlands | Research Site | Leiderdorp | |
| Netherlands | Research Site | Nijmegen | |
| Netherlands | Research Site | Purmerend | |
| Portugal | Research Site | Barreiro | |
| Portugal | Research Site | Cascais | |
| Portugal | Research Site | Coimbra | |
| Portugal | Research Site | Covilha | |
| Portugal | Research Site | Lisboa | |
| Portugal | Research Site | Martinho do Bispo | |
| Portugal | Research Site | Portimao | |
| Portugal | Research Site | Porto | |
| Portugal | Research Site | S. Martinho do Porto | |
| Portugal | Research Site | Santa Maria da Feira | |
| Portugal | Research Site | Setubal | |
| Portugal | Research Site | Vila Nova de Gaia | |
| Spain | Research Site | Alicante | |
| Spain | Research Site | Alzira, Valencia | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Elche | |
| Spain | Research Site | Las Palmas | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Malaga | |
| Spain | Research Site | Murcia | |
| Spain | Research Site | Ourense | |
| Spain | Research Site | Segovia | |
| Spain | Research Site | Sevilla | |
| Spain | Research Site | Terrassa | |
| Spain | Research Site | Toledo | |
| Spain | Research Site | Valencia | |
| Switzerland | Research Site | Aarau | |
| Switzerland | Research Site | Allschwil | |
| Switzerland | Research Site | Baden | |
| Switzerland | Research Site | Basel | |
| Switzerland | Research Site | Bern | |
| Switzerland | Research Site | Frauenfeld | |
| Switzerland | Research Site | Liestal | |
| Switzerland | Research Site | Luzern | |
| Switzerland | Research Site | Rorschach | |
| Switzerland | Research Site | Sion | |
| Switzerland | Research Site | St. Gallen | |
| Switzerland | Research Site | Sursee | |
| Switzerland | Research Site | Wetzikon | |
| Switzerland | Research Site | Zurich | |
| United Kingdom | Research Site | Basingstoke | |
| United Kingdom | Research Site | Bradford | |
| United Kingdom | Research Site | Brighton | |
| United Kingdom | Research Site | Bristol | |
| United Kingdom | Research Site | Cambridge | |
| United Kingdom | Research Site | Canterbury | |
| United Kingdom | Research Site | Glasgow | |
| United Kingdom | Research Site | Gloucester | |
| United Kingdom | Research Site | Leeds | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | Manchester | |
| United Kingdom | Research Site | Oxford | |
| United Kingdom | Research Site | Plymouth | |
| United Kingdom | Research Site | Reading | |
| United Kingdom | Research Site | Sheffield | |
| United Kingdom | Research Site | Southend-on-Sea | |
| United Kingdom | Research Site | Taunton | |
| United Kingdom | Research Site | Wales | |
| United Kingdom | Research Site | Wolverhampton |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca | A+A Healthcare Marketing Research, Freelance CRA (FCRA), RTI Health Solutions |
Australia, Belgium, Canada, France, Germany, Israel, Italy, Korea, Republic of, Netherlands, Portugal, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 |