Clinical trial NCT02262273: OSCA - Olaparib Standard of CAre Study
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Platinum-sensitive Recurrent Serous Ovarian Cancer
Keywords: women
platinum sensitive
recurrent
serous
ovarian cancer
BRCA
PARP
Olaparib
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: RTI Health Solutions
name: A+A Healthcare Marketing Research
name: Freelance CRA (FCRA)
First posted: 2014-10-13
Enrollment: 2123
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: platinum-sensitive recurrent serous ovarian cancer patients

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


Eligibility criteria: 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.

Primary outcomes:
measure: Best response to therapy and date of response for each subsequent therapy line post-index
timeFrame: Data will be collected retrospectively from medical records
Secondary outcomes:
measure: Progression-free survival, by therapy line
timeFrame: Data will be collected retrospectively from medical records
measure: Overall survival, calculated from various time points
timeFrame: Data will be collected retrospectively from medical records
Other outcomes:
Locations:
city: Ballarat
country: Australia
facility: Research Site
city: Birtinya
country: Australia
facility: Research Site
city: Campbelltown
country: Australia
facility: Research Site
city: East Melbourne
country: Australia
facility: Research Site
city: Mandurah, Western Australia
country: Australia
facility: Research Site
city: South Brisbane
country: Australia
facility: Research Site
city: St Leonards
country: Australia
facility: Research Site
city: Victoria
country: Australia
facility: Research Site
city: Waratah
country: Australia
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Namur
country: Belgium
facility: Research Site
city: Sint-Niklaas
country: Belgium
facility: Research Site
city: Alberta
country: Canada
facility: Research Site
city: Charlottetown
country: Canada
facility: Research Site
city: Mississauga
country: Canada
facility: Research Site
city: Montreal
country: Canada
facility: Research Site
city: Ottawa
country: Canada
facility: Research Site
city: Red Deer
country: Canada
facility: Research Site
city: Toronto
country: Canada
facility: Research Site
city: Vancouver
country: Canada
facility: Research Site
city: Aix En Provence
country: France
facility: Research Site
city: Ajaccio
country: France
facility: Research Site
city: Auxerre
country: France
facility: Research Site
city: Besancon
country: France
facility: Research Site
city: Beziers
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Bourg-en-bresse
country: France
facility: Research Site
city: Brest
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Chambery
country: France
facility: Research Site
city: Colombes
country: France
facility: Research Site
city: Grenoble
country: France
facility: Research Site
city: Libourne Cedex
country: France
facility: Research Site
city: Longjumeau
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Mont de Marsan
country: France
facility: Research Site
city: Montbeliard
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Mulhouse
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Narbonne
country: France
facility: Research Site
city: Quimper
country: France
facility: Research Site
city: Rennes Cedex
country: France
facility: Research Site
city: St Pierre Du Mont
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Tours Cedex 9
country: France
facility: Research Site
city: Villejuif
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bonn Bad Godesberg
country: Germany
facility: Research Site
city: Chemnitz
country: Germany
facility: Research Site
city: Dusseldorf
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Frankfurt am Main
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Hagen
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Heilbronn
country: Germany
facility: Research Site
city: Karlsruhe
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Koln
country: Germany
facility: Research Site
city: Kothen
country: Germany
facility: Research Site
city: Leverkusen
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Nurnberg
country: Germany
facility: Research Site
city: Osnabruck
country: Germany
facility: Research Site
city: Passau
country: Germany
facility: Research Site
city: Ratingen
country: Germany
facility: Research Site
city: Saarlouis
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
city: Velbert
country: Germany
facility: Research Site
city: Wetzlar
country: Germany
facility: Research Site
city: Afula
country: Israel
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Netanya
country: Israel
facility: Research Site
city: Petah Tikva
country: Israel
facility: Research Site
city: Rehovot
country: Israel
facility: Research Site
city: St. Holon
country: Israel
facility: Research Site
city: Tel Aviv
country: Israel
facility: Research Site
city: Tel Hashomer
country: Israel
facility: Research Site
city: Alessandria
country: Italy
facility: Research Site
city: Aosta
country: Italy
facility: Research Site
city: Ariano Irpino
country: Italy
facility: Research Site
city: Avellino
country: Italy
facility: Research Site
city: Bari
country: Italy
facility: Research Site
city: Brescia
country: Italy
facility: Research Site
city: Brindisi
country: Italy
facility: Research Site
city: Caltagirone
country: Italy
facility: Research Site
city: Candiolo
country: Italy
facility: Research Site
city: Carbonia
country: Italy
facility: Research Site
city: Castelfranco Veneto
country: Italy
facility: Research Site
city: Castellana Grotte
country: Italy
facility: Research Site
city: Castellaneta
country: Italy
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Figline Valdarno
country: Italy
facility: Research Site
city: Franca
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Gorizia
country: Italy
facility: Research Site
city: Gravina di Catania
country: Italy
facility: Research Site
city: Ivrea
country: Italy
facility: Research Site
city: Latina
country: Italy
facility: Research Site
city: Latisana
country: Italy
facility: Research Site
city: Lecce
country: Italy
facility: Research Site
city: Lido di Ostia
country: Italy
facility: Research Site
city: Manduria
country: Italy
facility: Research Site
city: Manerbi
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Monselice
country: Italy
facility: Research Site
city: Monserrato
country: Italy
facility: Research Site
city: Monza
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Orbassano
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Palmanova
country: Italy
facility: Research Site
city: Ponte a Niccheri
country: Italy
facility: Research Site
city: Portogruaro
country: Italy
facility: Research Site
city: Reggio Calabria
country: Italy
facility: Research Site
city: Rieti
country: Italy
facility: Research Site
city: Rionero in Vulture
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: San Gavino Monreale
country: Italy
facility: Research Site
city: Santorso VI
country: Italy
facility: Research Site
city: Seriate
country: Italy
facility: Research Site
city: Sesto San Giovanni
country: Italy
facility: Research Site
city: Solofra
country: Italy
facility: Research Site
city: Taranto
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Trieste
country: Italy
facility: Research Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Dordrecht
country: Netherlands
facility: Research Site
city: Enschede
country: Netherlands
facility: Research Site
city: Leiderdorp
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Purmerend
country: Netherlands
facility: Research Site
city: Barreiro
country: Portugal
facility: Research Site
city: Cascais
country: Portugal
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Covilha
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Martinho do Bispo
country: Portugal
facility: Research Site
city: Portimao
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: S. Martinho do Porto
country: Portugal
facility: Research Site
city: Santa Maria da Feira
country: Portugal
facility: Research Site
city: Setubal
country: Portugal
facility: Research Site
city: Vila Nova de Gaia
country: Portugal
facility: Research Site
city: Alicante
country: Spain
facility: Research Site
city: Alzira, Valencia
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Elche
country: Spain
facility: Research Site
city: Las Palmas
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Ourense
country: Spain
facility: Research Site
city: Segovia
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Terrassa
country: Spain
facility: Research Site
city: Toledo
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Aarau
country: Switzerland
facility: Research Site
city: Allschwil
country: Switzerland
facility: Research Site
city: Baden
country: Switzerland
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Frauenfeld
country: Switzerland
facility: Research Site
city: Liestal
country: Switzerland
facility: Research Site
city: Luzern
country: Switzerland
facility: Research Site
city: Rorschach
country: Switzerland
facility: Research Site
city: Sion
country: Switzerland
facility: Research Site
city: St. Gallen
country: Switzerland
facility: Research Site
city: Sursee
country: Switzerland
facility: Research Site
city: Wetzikon
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
city: Basingstoke
country: United Kingdom
facility: Research Site
city: Bradford
country: United Kingdom
facility: Research Site
city: Brighton
country: United Kingdom
facility: Research Site
city: Bristol
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Canterbury
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Gloucester
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
city: Plymouth
country: United Kingdom
facility: Research Site
city: Reading
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Southend-on-Sea
country: United Kingdom
facility: Research Site
city: Taunton
country: United Kingdom
facility: Research Site
city: Wales
country: United Kingdom
facility: Research Site
city: Wolverhampton
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Steering Committee/Advisory Board Members
name: Nicoletta Colombo, MD
role: STUDY_DIRECTOR
affiliation: Steering Committee/Advisory Board Members
name: Laurence Gladieff, MD
role: STUDY_DIRECTOR
affiliation: Steering Committee/Advisory Board Members
name: Sven Mahner, MD
role: STUDY_DIRECTOR
affiliation: Steering Committee/Advisory Board Members
name: Isabel Bover, MD
role: STUDY_DIRECTOR
affiliation: Steering Committee/Advisory Board Members
name: Jacob Korach, MD
role: STUDY_DIRECTOR
References: