Characterizing the Cross-sectional Approach to Investigate the Prevalence of Tissue BRCA1/2 Mutations in Newly Diagnosed Advanced Ovarian Cancer Patients

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    AstraZeneca
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Updated on 19 February 2024
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cancer
metastasis
formalin-fixed paraffin-embedded
ovarian cancer
primary peritoneal carcinoma
peritoneal cancer
ovarian epithelial cancer
BRCA1/2
BRCA1

Summary

This is a multi-center, observational study in Japan. Patients with newly diagnosed FIGO stage III - IV advanced OC will be enrolled sequentially.

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

Description

Study design:This is a multi-center, observational study in Japan. Patients with newly diagnosed FIGO stage III - IV advanced OC will be enrolled sequentially.

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.

Details
Condition Ovarian disorder, Ovarian Cancer, Ovarian Cancer
Age 20years - 100years
Clinical Study IdentifierNCT04222465
SponsorAstraZeneca
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Aged 20 years or older of Japanese women at the time of consent (the age of death, in case of dead patient)
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

Patients who are not recommended enrolling this study decided by physician
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