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| Name | Class |
|---|---|
| RTI Health Solutions | OTHER |
| A+A Healthcare Marketing Research | INDUSTRY |
| Freelance CRA (FCRA) | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serous ovarian cancer: | Women with platinum-sensitive recurrent serous ovarian cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data Collection | Other | Colleciton of data from medical records only |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
1. Ever taken an investigational product as part of an interventional clinical trial for ovarian cancer.
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platinum-sensitive recurrent serous ovarian cancer patients
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| Name | Affiliation | Role |
|---|---|---|
| Nicoletta Colombo, MD | Steering Committee/Advisory Board Members | Study Director |
| Laurence Gladieff, MD | Steering Committee/Advisory Board Members | Study Director |
| Sven Mahner, MD | Steering Committee/Advisory Board Members | Study Director |
| Isabel Bover, MD | Steering Committee/Advisory Board Members | Study Director |
| Jacob Korach, MD | Steering Committee/Advisory Board Members | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ballarat | Australia | ||||
| Research Site |
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| Label | URL |
|---|---|
| D0816R00004\_CSR\_Synopsis\_23Feb2017.pdf | View source |
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| 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 |
| 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 | Australia |
| Research Site | Edegem | Belgium |
| Research Site | Namur | Belgium |
| Research Site | Sint-Niklaas | Belgium |
| 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 | Canada |
| Research Site | Aix-en-Provence | France |
| Research Site | Ajaccio | France |
| Research Site | Auxerre | France |
| Research Site | Besançon | France |
| Research Site | Béziers | France |
| Research Site | Bordeaux | France |
| Research Site | Bourg-en-Bresse | France |
| Research Site | Brest | France |
| Research Site | Caen | France |
| Research Site | Chambéry | France |
| Research Site | Colombes | France |
| Research Site | Grenoble | France |
| Research Site | Libourne | France |
| Research Site | Longjumeau | France |
| Research Site | Lyon | France |
| Research Site | Marseille | France |
| Research Site | Mont-de-Marsan | France |
| Research Site | Montbéliard | France |
| Research Site | Montpellier | France |
| Research Site | Mulhouse | France |
| Research Site | Nantes | France |
| Research Site | Narbonne | France |
| Research Site | Quimper | France |
| Research Site | Rennes | France |
| Research Site | Saint-Pierre-du-Mont | France |
| Research Site | Strasbourg | France |
| Research Site | Toulouse | France |
| Research Site | Tours | France |
| Research Site | Villejuif | France |
| Research Site | Bad Godesberg | Germany |
| Research Site | Berlin | Germany |
| Research Site | Chemnitz | Germany |
| Research Site | Cologne | Germany |
| Research Site | Düsseldorf | 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 | Köthen | Germany |
| Research Site | Leverkusen | Germany |
| Research Site | München | Germany |
| Research Site | Nuremberg | Germany |
| Research Site | Osnabrück | 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 | Germany |
| 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 | Saint Holon | Israel |
| Research Site | Tel Aviv | Israel |
| Research Site | Tel Litwinsky | Israel |
| 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 | Milan | Italy |
| Research Site | Monselice | Italy |
| Research Site | Monserrato | Italy |
| Research Site | Monza | Italy |
| Research Site | Naples | 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 | Italy |
| Research Site | Dordrecht | Netherlands |
| Research Site | Enschede | Netherlands |
| Research Site | Leiderdorp | Netherlands |
| Research Site | Nijmegen | Netherlands |
| Research Site | Purmerend | Netherlands |
| Research Site | Barreiro | Portugal |
| Research Site | Cascais | Portugal |
| Research Site | Coimbra | Portugal |
| Research Site | Covilha | Portugal |
| Research Site | Lisbon | Portugal |
| Research Site | Martinho Do Bispo | Portugal |
| Research Site | Portimão | Portugal |
| Research Site | Porto | Portugal |
| Research Site | S. Martinho Do Porto | Portugal |
| Research Site | Santa Maria da Feira | Portugal |
| Research Site | Setúbal | Portugal |
| Research Site | Vila Nova de Gaia | Portugal |
| Research Site | Gyeonggi-do | South Korea |
| Research Site | Seoul | South Korea |
| 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 | Málaga | Spain |
| Research Site | Murcia | Spain |
| Research Site | Ourense | Spain |
| Research Site | Segovia | Spain |
| Research Site | Seville | Spain |
| Research Site | Terrassa | Spain |
| Research Site | Toledo | Spain |
| Research Site | Valencia | Spain |
| 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 | Lucerne | Switzerland |
| Research Site | Rorschach | Switzerland |
| Research Site | Sankt Gallen | Switzerland |
| Research Site | Sion | Switzerland |
| Research Site | Sursee | Switzerland |
| Research Site | Wetzikon | Switzerland |
| Research Site | Zurich | Switzerland |
| 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 | United Kingdom |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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