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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02262273




Registration number
NCT02262273
Ethics application status
Date submitted
6/10/2014
Date registered
13/10/2014
Date last updated
1/03/2017

Titles & IDs
Public title
OSCA - Olaparib Standard of CAre Study
Scientific 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
Secondary ID [1] 0 0
D0816R00004
Universal Trial Number (UTN)
Trial acronym
OSCA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Platinum-sensitive Recurrent Serous Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Data Collection

Serous ovarian cancer: - Women with platinum-sensitive recurrent serous ovarian cancer


Other interventions: Data Collection
Colleciton of data from medical records only

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
Data will be collected retrospectively from medical records
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
Data will be collected retrospectively from medical records
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Data will be collected retrospectively from medical records

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Ever taken an investigational product as part of an interventional clinical trial for
ovarian cancer.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Ballarat
Recruitment hospital [2] 0 0
Research Site - Birtinya
Recruitment hospital [3] 0 0
Research Site - Campbelltown
Recruitment hospital [4] 0 0
Research Site - East Melbourne
Recruitment hospital [5] 0 0
Research Site - Mandurah, Western Australia
Recruitment hospital [6] 0 0
Research Site - South Brisbane
Recruitment hospital [7] 0 0
Research Site - St Leonards
Recruitment hospital [8] 0 0
Research Site - Victoria
Recruitment hospital [9] 0 0
Research Site - Waratah
Recruitment postcode(s) [1] 0 0
- Ballarat
Recruitment postcode(s) [2] 0 0
- Birtinya
Recruitment postcode(s) [3] 0 0
- Campbelltown
Recruitment postcode(s) [4] 0 0
- East Melbourne
Recruitment postcode(s) [5] 0 0
- Mandurah, Western Australia
Recruitment postcode(s) [6] 0 0
- South Brisbane
Recruitment postcode(s) [7] 0 0
- St Leonards
Recruitment postcode(s) [8] 0 0
- Victoria
Recruitment postcode(s) [9] 0 0
- Waratah
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Edegem
Country [2] 0 0
Belgium
State/province [2] 0 0
Namur
Country [3] 0 0
Belgium
State/province [3] 0 0
Sint-Niklaas
Country [4] 0 0
Canada
State/province [4] 0 0
Alberta
Country [5] 0 0
Canada
State/province [5] 0 0
Charlottetown
Country [6] 0 0
Canada
State/province [6] 0 0
Mississauga
Country [7] 0 0
Canada
State/province [7] 0 0
Montreal
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Canada
State/province [8] 0 0
Ottawa
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Canada
State/province [9] 0 0
Red Deer
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Canada
State/province [10] 0 0
Toronto
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Canada
State/province [11] 0 0
Vancouver
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France
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Aix En Provence
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Ajaccio
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France
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Auxerre
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France
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Besancon
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France
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Beziers
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Bordeaux
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France
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Bourg-en-bresse
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France
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Brest
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France
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Caen
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Chambery
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Colombes
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Grenoble
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France
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Libourne Cedex
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Longjumeau
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Lyon
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Marseille
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Mont de Marsan
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Montbeliard
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Montpellier
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Mulhouse
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Nantes
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Narbonne
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France
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Quimper
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France
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Rennes Cedex
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France
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St Pierre Du Mont
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France
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Strasbourg
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Toulouse
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Tours Cedex 9
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France
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Villejuif
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Germany
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Berlin
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Bonn Bad Godesberg
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Germany
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Chemnitz
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Dusseldorf
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Germany
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Erlangen
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Essen
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Germany
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Frankfurt am Main
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Frankfurt
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Germany
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Hagen
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Heilbronn
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Karlsruhe
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Kiel
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Koln
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Kothen
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Germany
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Leverkusen
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Munchen
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Germany
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Nurnberg
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Osnabruck
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Passau
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Ratingen
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Saarlouis
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Stuttgart
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Ulm
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Velbert
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Germany
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Wetzlar
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Israel
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Israel
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Haifa
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Jerusalem
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Israel
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Netanya
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Israel
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Petah Tikva
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Israel
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Rehovot
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Israel
State/province [74] 0 0
St. Holon
Country [75] 0 0
Israel
State/province [75] 0 0
Tel Aviv
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Israel
State/province [76] 0 0
Tel Hashomer
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Italy
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Aosta
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Brescia
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Brindisi
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Candiolo
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Carbonia
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Castelfranco Veneto
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Italy
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Castellana Grotte
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Castellaneta
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Catania
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Figline Valdarno
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Franca
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Genova
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Italy
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Gorizia
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Italy
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Gravina di Catania
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Italy
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Ivrea
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Italy
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Latina
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Latisana
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Basel
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Bern
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Frauenfeld
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Liestal
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Sursee
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Basingstoke
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Bradford
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Brighton
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Bristol
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Cambridge
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Canterbury
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Glasgow
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Gloucester
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Leeds
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London
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Manchester
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Oxford
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Taunton
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Wales
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State/province [190] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
RTI Health Solutions
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
A+A Healthcare Marketing Research
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Freelance CRA (FCRA)
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT02262273
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nicoletta Colombo, MD
Address 0 0
Steering Committee/Advisory Board Members
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications