Characterizing the Cross-sectional Approach to Investigate the Prevalence of Tissue BRCA1/2 Mutations in Newly Diagnosed Advanced Ovarian Cancer Patients
NCT ID: NCT04222465
Last Updated: 2021-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
207 participants
OBSERVATIONAL
2020-03-19
2020-11-13
Brief Summary
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In this study, data of 200 subjects will be collected at approximately 20 sites in Japan. To reduce regional bias of study sites, the number of enrolled patients per site will be capped
Detailed Description
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In this study, data of 200 subjects will be collected at approximately 20 sites in Japan. To reduce regional bias of study sites, the number of enrolled patients per site will be capped.
Study population:Patients with FIGO stage III - IV epithelial ovarian cancer Drug exposure:Not applicable Planned study sites and sample size:The objective number of patients will be 200 from approximately 20 hospitals.
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed as advanced OC (FIGO stage III - IV) with epithelial ovarian cancer, primary peritoneal cancer or fallopian-tube cancer \[or a combination of these cancers\] after January 1, 2019
* Patients who have archived formalin-fixed paraffin-embedded (FFPE) samples of primary or peritoneal metastatic tumor collected after January 1, 2019
* Patients who have undergone or are scheduled to undergo BRACAnalysis
* Patients who give their written informed consent to participate in this study (However, the cases of death should be handled in accordance with the instructions of the Ethical Review Board of each site.)
Exclusion Criteria
20 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Matsuyama, Ehime, Japan
Research Site
Tōon, Ehime, Japan
Research Site
Yoshida, Fukui, Japan
Research Site
Kitakyushu, Fukuoka, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Amagasaki, Hyōgo, Japan
Research Site
Kobe, Hyōgo, Japan
Research Site
Tsukuba, Ibaraki, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Kashihara, Nara, Japan
Research Site
Izumo, Shimane, Japan
Research Site
Bunkyo, Tokyo, Japan
Research Site
Minato, Tokyo, Japan
Research Site
Musashino, Tokyo, Japan
Research Site
Shinjuku, Tokyo, Japan
Research Site
Fukushima, , Japan
Research Site
Gifu, , Japan
Research Site
Kumamoto, , Japan
Research Site
Niigata, , Japan
Research Site
Yamagata, , Japan
Countries
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Related Links
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Other Identifiers
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D0817R00018
Identifier Type: -
Identifier Source: org_study_id