Study identifier:D0818R00008
ClinicalTrials.gov identifier:NCT05775549
EudraCT identifier:N/A
CTIS identifier:N/A
FLAME - First Line olAparib Maintenance bEyond BRCA An Observational Cohort Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy Beyond BRCA Mutant Status in Newly Diagnosed Advanced Ovarian Cancer
Advanced Ovarian cancer
Phase 4
No
-
Female
24
Observational
18 Years - 130 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
Merck
This study will collect the data from existing patient medical records at US cancer centers. The study will include patients with BRCAwt ovarian cancer who have been prescribed first line (1L) olaparib maintenance treatment.
This is a United States (US) based multicenter, retrospective, observational cohort study with data abstracted from patient medical records. In this observational study, it is planned to include approximately 150 US female patients with newly diagnosed advanced ovarian cancer (AOC) who were tumor biomarker tested between first diagnosis with AOC and first prescription of 1L olaparib maintenance monotherapy as tumor breast cancer gene wild type (BRCAwt) with a known homologous recombination deficiency (HRD) status. This retrospective cohort study will include patients with first olaparib prescription between Jan 2017 and Dec 2021. All data collection will be retrospective. Data will be collected from the date of first olaparib prescription (index date) with a follow-up period of at least 18 months post index date.
Location
Location
New York, New York, United States, 10032
Location
Tampa, Florida, United States, 33606
Location
Madison, Wisconsin, United States, 53792
Location
Baltimore, Maryland, United States, 21287
Location
Annapolis, Maryland, United States, 21401
Location
Charlotte, North Carolina, United States, 28204
Location
Shreveport, Louisiana, United States, 71103
Arms | Assigned Interventions |
---|---|
Retrospective Cohort Patients with newly diagnosed AOC BRCAwt with known HRD status who have been prescribed 1L olaparib maintenance treatment. | - |
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