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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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
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Secondary ID [1]
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0
D0816R00004
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Universal Trial Number (UTN)
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Trial acronym
OSCA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Platinum-sensitive Recurrent Serous Ovarian Cancer
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Condition category
Condition code
Cancer
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0
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0
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Ovarian and primary peritoneal
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Inflammatory and Immune System
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0
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0
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Allergies
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Other
0
0
0
0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Best response to therapy and date of response for each subsequent therapy line post-index
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Assessment method [1]
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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).
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Timepoint [1]
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Data will be collected retrospectively from medical records
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Secondary outcome [1]
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Progression-free survival, by therapy line
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Assessment method [1]
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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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Timepoint [1]
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Data will be collected retrospectively from medical records
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Secondary outcome [2]
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Overall survival, calculated from various time points
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Assessment method [2]
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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
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Timepoint [2]
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Data will be collected retrospectively from medical records
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Ever taken an investigational product as part of an interventional clinical trial for ovarian cancer.
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2016
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Sample size
Target
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Accrual to date
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Final
2123
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Ballarat
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Recruitment hospital [2]
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Research Site - Birtinya
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Research Site - Campbelltown
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Recruitment postcode(s) [1]
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- Ballarat
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Recruitment postcode(s) [2]
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- Birtinya
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Recruitment postcode(s) [3]
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- Campbelltown
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- East Melbourne
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Recruitment postcode(s) [5]
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- Mandurah, Western Australia
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Recruitment postcode(s) [6]
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- South Brisbane
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Recruitment postcode(s) [7]
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- St Leonards
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Recruitment postcode(s) [8]
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- Victoria
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Recruitment postcode(s) [9]
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- Waratah
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Recruitment outside Australia
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Belgium
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Edegem
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Martinho do Bispo
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Portugal
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Portimao
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Portugal
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Porto
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Portugal
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S. Martinho do Porto
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Portugal
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Santa Maria da Feira
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Portugal
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Setubal
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Portugal
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Vila Nova de Gaia
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Spain
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Alicante
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Spain
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Alzira, Valencia
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Spain
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Barcelona
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Spain
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Elche
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Spain
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Las Palmas
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Murcia
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Spain
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Ourense
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Spain
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Segovia
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Sevilla
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Terrassa
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Toledo
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Spain
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Valencia
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Switzerland
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Aarau
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Switzerland
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Allschwil
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Country [160]
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Switzerland
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Baden
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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Frauenfeld
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Switzerland
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Liestal
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Switzerland
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Luzern
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Switzerland
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Rorschach
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Switzerland
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Sion
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Switzerland
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St. Gallen
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Switzerland
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Sursee
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Switzerland
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Wetzikon
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Switzerland
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Zurich
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United Kingdom
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Basingstoke
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Bradford
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Brighton
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Bristol
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United Kingdom
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Cambridge
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United Kingdom
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Canterbury
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Country [178]
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United Kingdom
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Glasgow
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United Kingdom
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Gloucester
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Oxford
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Plymouth
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Reading
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United Kingdom
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Sheffield
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Southend-on-Sea
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Taunton
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Wales
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Other collaborator category [1]
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Other
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Name [1]
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RTI Health Solutions
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Other collaborator category [2]
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Commercial sector/industry
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A+A Healthcare Marketing Research
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Other collaborator category [3]
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Other
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Freelance CRA (FCRA)
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Ethics approval
Ethics application status
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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
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Trial website
https://clinicaltrials.gov/study/NCT02262273
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Nicoletta Colombo, MD
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02262273
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