OSCA - Olaparib Standard of CAre Study (OSCA)

February 28, 2017 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2123

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • 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, Australia
        • Research Site
  • Belgium
      • Edegem, Belgium
        • Research Site
      • Namur, Belgium
        • Research Site
      • Sint-Niklaas, Belgium
        • Research Site
  • Canada
      • 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
  • France
      • 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, France
        • Research Site
  • Germany
      • 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, Germany
        • Research Site
  • Israel
      • 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, Israel
        • Research Site
  • Italy
      • 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, Italy
        • Research Site
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
  • Netherlands
      • Dordrecht, Netherlands
        • Research Site
      • Enschede, Netherlands
        • Research Site
      • Leiderdorp, Netherlands
        • Research Site
      • Nijmegen, Netherlands
        • Research Site
      • Purmerend, Netherlands
        • Research Site
  • Portugal
      • 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, Portugal
        • Research Site
  • Spain
      • 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, Spain
        • Research Site
  • Switzerland
      • 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, Switzerland
        • Research Site
  • United Kingdom
      • 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
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

platinum-sensitive recurrent serous ovarian cancer patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Serous ovarian cancer:
Women with platinum-sensitive recurrent serous ovarian cancer
Other: Data Collection
Colleciton of data from medical records only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best response to therapy and date of response for each subsequent therapy line post-index
Time Frame: Data will be collected retrospectively from medical records
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
Time Frame: Data will be collected retrospectively from medical records
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
Time Frame: Data will be collected retrospectively from medical records
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

RTI Health Solutions
A+A Healthcare Marketing Research
Freelance CRA (FCRA)

Investigators

  • Study Director: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

October 6, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0816R00004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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