OSCA - Olaparib Standard of CAre Study

NCT02262273 | Completed

• 1 other identifier: D0816R00004
• Study Type: observational
• Target: 2,123
• Locations: 13 countries
• Sites: 199

Brief Summary

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

Conditions

Platinum-sensitive Recurrent Serous Ovarian Cancer

Keywords

women; platinum sensitive; recurrent; serous; ovarian cancer; BRCA; PARP; Olaparib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression-free survival, by therapy line

  Data will be collected retrospectively from medical records

• Overall survival, calculated from various time points

  Data will be collected retrospectively from medical records

Study Arms (1)

Serous ovarian cancer:

Women with platinum-sensitive recurrent serous ovarian cancer

Other: Data Collection

Interventions

Data Collection OTHER

Colleciton of data from medical records only

Serous ovarian cancer:

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

platinum-sensitive recurrent serous ovarian cancer patients

You may qualify if:

• 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.

You may not qualify if:

• \. Ever taken an investigational product as part of an interventional clinical trial for ovarian cancer.

Sponsors & Collaborators

• AstraZeneca: lead
• RTI Health Solutions: collaborator
• A+A Healthcare Marketing Research: collaborator
• Freelance CRA (FCRA): collaborator

Study Sites (199)

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Ballarat, Australia

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Birtinya, Australia

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Campbelltown, Australia

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East Melbourne, Australia

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Mandurah, Western Australia, Australia

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South Brisbane, Australia

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St Leonards, Australia

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Victoria, Australia

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Waratah, Australia

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Edegem, Belgium

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Namur, Belgium

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Sint-Niklaas, Belgium

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Alberta, Canada

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Charlottetown, Canada

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Mississauga, Canada

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Montreal, Canada

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Ottawa, Canada

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Red Deer, Canada

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Toronto, Canada

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Vancouver, Canada

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Aix-en-Provence, France

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Ajaccio, France

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Auxerre, France

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Besançon, France

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Béziers, France

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Bordeaux, France

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Bourg-en-Bresse, France

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Brest, France

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Caen, France

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Chambéry, France

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Colombes, France

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Grenoble, France

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Libourne, France

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Longjumeau, France

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Lyon, France

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Marseille, France

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Mont-de-Marsan, France

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Montbéliard, France

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Montpellier, France

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Mulhouse, France

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Nantes, France

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Narbonne, France

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Quimper, France

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Rennes, France

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Saint-Pierre-du-Mont, France

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Strasbourg, France

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Toulouse, France

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Tours, France

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Villejuif, France

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Bad Godesberg, Germany

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Berlin, Germany

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Chemnitz, Germany

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Cologne, Germany

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Düsseldorf, Germany

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Erlangen, Germany

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Essen, Germany

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Frankfurt, Germany

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Frankfurt am Main, Germany

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Hagen, Germany

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Hamburg, Germany

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Heidelberg, Germany

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Heilbronn, Germany

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Karlsruhe, Germany

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Kiel, Germany

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Köthen, Germany

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Leverkusen, Germany

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München, Germany

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Nuremberg, Germany

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Osnabrück, Germany

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Passau, Germany

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Ratingen, Germany

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Saarlouis, Germany

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Stuttgart, Germany

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Ulm, Germany

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Velbert, Germany

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Wetzlar, Germany

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Afula, Israel

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Haifa, Israel

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Jerusalem, Israel

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Netanya, Israel

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Petah Tikva, Israel

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Rehovot, Israel

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Saint Holon, Israel

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Tel Aviv, Israel

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Tel Litwinsky, Israel

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Alessandria, Italy

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Aosta, Italy

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Ariano Irpino, Italy

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Avellino, Italy

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Bari, Italy

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Brescia, Italy

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Brindisi, Italy

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Caltagirone, Italy

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Candiolo, Italy

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Carbonia, Italy

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Castelfranco Veneto, Italy

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Castellana Grotte, Italy

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Castellaneta, Italy

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Catania, Italy

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Figline Valdarno, Italy

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Franca, Italy

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Genova, Italy

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Gorizia, Italy

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Gravina di Catania, Italy

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Ivrea, Italy

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Latina, Italy

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Latisana, Italy

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Lecce, Italy

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Lido di Ostia, Italy

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Manduria, Italy

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Manerbi, Italy

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Milan, Italy

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Monselice, Italy

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Monserrato, Italy

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Monza, Italy

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Napoli, Italy

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Orbassano, Italy

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Padua, Italy

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Palmanova, Italy

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Ponte A Niccheri, Italy

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Portogruaro, Italy

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Reggio Calabria, Italy

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Rieti, Italy

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Rionero in Vulture, Italy

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Roma, Italy

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San Gavino Monreale, Italy

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Santorso VI, Italy

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Seriate, Italy

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Sesto San Giovanni, Italy

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Solofra, Italy

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Taranto, Italy

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Torino, Italy

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Trieste, Italy

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Dordrecht, Netherlands

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Enschede, Netherlands

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Leiderdorp, Netherlands

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Nijmegen, Netherlands

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Purmerend, Netherlands

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Barreiro, Portugal

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Cascais, Portugal

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Coimbra, Portugal

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Covilha, Portugal

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Lisbon, Portugal

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Martinho Do Bispo, Portugal

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Portimão, Portugal

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Porto, Portugal

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S. Martinho Do Porto, Portugal

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Santa Maria da Feira, Portugal

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Setúbal, Portugal

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Vila Nova de Gaia, Portugal

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Gyeonggi-do, South Korea

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Seoul, South Korea

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Alicante, Spain

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Alzira, Valencia, Spain

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Barcelona, Spain

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Elche, Spain

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Las Palmas, Spain

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Madrid, Spain

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Málaga, Spain

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Murcia, Spain

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Ourense, Spain

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Segovia, Spain

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Seville, Spain

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Terrassa, Spain

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Toledo, Spain

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Valencia, Spain

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Aarau, Switzerland

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Allschwil, Switzerland

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Baden, Switzerland

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Basel, Switzerland

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Bern, Switzerland

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Frauenfeld, Switzerland

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Liestal, Switzerland

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Lucerne, Switzerland

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Rorschach, Switzerland

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Sankt Gallen, Switzerland

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Sion, Switzerland

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Sursee, Switzerland

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Wetzikon, Switzerland

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Zurich, Switzerland

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Basingstoke, United Kingdom

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Bradford, United Kingdom

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Brighton, United Kingdom

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Bristol, United Kingdom

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Cambridge, United Kingdom

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Canterbury, United Kingdom

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Glasgow, United Kingdom

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Gloucester, United Kingdom

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Leeds, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Oxford, United Kingdom

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Plymouth, United Kingdom

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Reading, United Kingdom

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Sheffield, United Kingdom

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Southend-on-Sea, United Kingdom

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Taunton, United Kingdom

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Wales, United Kingdom

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Wolverhampton, United Kingdom

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Related Links

• D0816R00004\_CSR\_Synopsis\_23Feb2017.pdf

MeSH Terms

Conditions

Recurrence; Ovarian Neoplasms

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 13, 2014
• Study Start: October 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

CH (14); ES (14); IT (48); BE (3); IL (9); PT (12); CA (8); GB (19); KR (2); AU (9); DE (27); FR (29); NL (5)