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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
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      • Bourg-en-bresse, France
        • Research Site
      • Brest, France
        • Research Site
      • Caen, France
        • Research Site
      • Chambery, France
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      • Colombes, France
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      • 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
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      • Nantes, France
        • Research Site
      • Narbonne, France
        • Research Site
      • Quimper, France
        • Research Site
      • Rennes Cedex, France
        • Research Site
      • St Pierre Du Mont, France
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      • Strasbourg, France
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      • Toulouse, France
        • Research Site
      • Tours Cedex 9, France
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      • Villejuif, France
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  • Germany
      • Berlin, Germany
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      • Bonn Bad Godesberg, Germany
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      • Chemnitz, Germany
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      • Dusseldorf, 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
        • Research Site
      • Hamburg, Germany
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      • 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
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      • Osnabruck, 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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  • Israel
      • Afula, Israel
        • Research Site
      • Haifa, Israel
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      • Jerusalem, Israel
        • Research Site
      • Netanya, Israel
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      • Petah Tikva, Israel
        • Research Site
      • Rehovot, Israel
        • Research Site
      • St. Holon, Israel
        • Research Site
      • Tel Aviv, Israel
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      • Tel Hashomer, Israel
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  • 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
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      • Portimao, Portugal
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      • Porto, Portugal
        • Research Site
      • S. Martinho do Porto, Portugal
        • Research Site
      • Santa Maria da Feira, Portugal
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      • Setubal, Portugal
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      • Vila Nova de Gaia, Portugal
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  • Spain
      • Alicante, Spain
        • Research Site
      • Alzira, Valencia, Spain
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      • Barcelona, Spain
        • Research Site
      • Elche, Spain
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      • Las Palmas, Spain
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      • 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
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      • 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
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      • Oxford, United Kingdom
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      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
RTI Health Solutions
A+A Healthcare Marketing Research
Freelance CRA (FCRA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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