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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
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.
Age
18 - 130 years
Sex
FEMALE
Healthy Volunteers
No
Research Site
Tampa, Florida, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Annapolis, Maryland, United States
Research Site
Baltimore, Maryland, United States
Research Site
New York, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Madison, Wisconsin, United States
Start Date
July 10, 2023
Primary Completion Date
October 27, 2023
Completion Date
October 27, 2023
Last Updated
September 20, 2024
24
ACTUAL participants
None (Observational Study)
OTHER
Lead Sponsor
AstraZeneca
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01262014