873
Participants
Start Date
March 13, 2017
Primary Completion Date
May 20, 2019
Study Completion Date
May 20, 2019
Germline BRCA Test (blood)
If unavailable from the patient medical records, gBRCA gene mutation status will be tested as aligned to local clinical practice using a blood sample obtained preferably during routine clinical practice. (Note: Blood samples may be shipped to a central laboratory for testing and storage, based on local regulations for shipment of blood samples.)
FoundationOne Dx Genomic Profile (archival Tumour Specimen)
"Archival tumour specimen will be requested from all patients in the informed consent, but is not required for study enrolment (optional consent). Where sufficient archival tumour specimen is available and patients have consented to tumour specimen testing, FoundationOne Dx genomic profiling may take place as follows:~* Tumour Specimen: Acceptable samples include formalin-fixed, paraffin embedded (FFPE) tissue (preferred) or FFPE specimens, including core needle biopsies, fine-needle aspirates and effusion cytologies.~* Tumour Testing (optional): archival tumour specimens, where available, will be tested for mutations in HRR genes including BRCA1 and BRCA2 and other genomic alterations using the FoundationOne Dx genomic profile."
Follow-up
"Patients who test positive for a gBRCA gene mutation, and/or sBRCA or other HRR gene mutations (optional testing), will be followed prospectively for assessment of treatment patterns and associated clinical outcomes up to 30-months.~\- Patients who test negative for gBRCA gene mutations, sBRCA and other HRR gene mutations, no further data will be collected post baseline. Patients presenting other genomic alterations that are identified by the FoundationOne Dx genomic profile will not continue beyond baseline as part of this study."
Research Site, Newport News
Research Site, Hialeah
Research Site, Flower Mound
Research Site, Dallas
Research Site, Paris
Research Site, Denton
Research Site, Houston
Research Site, Houston
Research Site, The Woodlands
Research Site, San Antonio
Research Site, Denver
Research Site, Santa Barbara
Research Site, Vancouver
Research Site, Wenatchee
Research Site, Redcliffe
Research Site, Kurralta Park
Research Site, Ballarat
Research Site, Dobrich
Research Site, Rousse
Research Site, Sofia
Research Site, Tübingen
Research Site, Budapest
Research Site, Szeged
Research Site, Szekszárd
Research Site, Szolnok
Research Site, Carpi
Research Site, Castellanza
Research Site, Milan
Research Site, Pavia
Research Site, Reggio Emilia
Research Site, Kamogawa-shi
Research Site, Matsuyama
Research Site, Fukuoka
Research Site, Sapporo
Research Site, Sendai
Research Site, Osaka
Research Site, Chūōku
Research Site, Brzozów
Research Site, Opole
Research Site, Warsaw
Research Site, Wałbrzych
Research Site, Wieliszew
Research Site, Wroclaw
Research Site, Żory
Research Site, Chelyabinsk
Research Site, Krasnodar
Research Site, Novosibirsk
Research Site, Omsk
Research Site, Pyatigorsk
Research Site, Ryazan
Research Site, Tomsk
Research Site, Goyang-si
Research Site, Seongnam-si
Research Site, Busan
Research Site, Seoul
Research Site, Ulsan
Research Site, Terrassa
Research Site, A Coruña
Research Site, Alcorcón
Research Site, San Sebastián de los Reyes
Research Site, Barcelona
Research Site, Burgos
Research Site, Girona
Research Site, Huelva
Research Site, Changhua
Research Site, Kaohsiung City
Research Site, Taichung
Research Site, Tainan City
Research Site, Taipei
Research Site, Adana
Research Site, Ankara
Research Site, Antalya
Research Site, Diyarbakır
Research Site, Istanbul
Research Site, Izmir
Research Site, Kocaeli
Research Site, Sakarya
Research Site, Samsun
Research Site, Tekirdağ
Research Site, Trabzon
Research Site, Van
Research Site, Huntingdon
Research Site, Peterborough
Research Site, Truro
Research Site, Derby
Research Site, Exeter
Research Site, Worthing
Research Site, London
Research Site, Blackpool
Research Site, Lancaster
Research Site, Stoke-on-Trent
Research Site, Warwick
Research Site, Wolverhampton
Research Site, Huddersfield
Research Site, Kingston
Research Site, Kitchener
Research Site, Chicoutimi
Research Site, Québec
Lead Sponsor
Quintiles; University of Tubingen - Germany
UNKNOWN
AstraZeneca
INDUSTRY