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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 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.
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| Measure | Description | Time Frame |
|---|---|---|
| The prevalence of tBRCAm in the newly diagnosed advanced OC patients | For BRCA1 and BRCA2 mutations detected by Myriad myChoice HRD, the number and percentage of patients with the following results will be indicated; deleterious mutation / suspected deleterious / variant of uncertain significance (VUS) / favour polymorphism / no mutation detected | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| The prevalence of gBRCAm in the subjects | For BRCA1 and BRCA2 mutations detected by BRACAnalysis, the number and percentage of patients with the following results will be indicated; deleterious mutation / suspected deleterious / variant of uncertain significance (VUS) / favour polymorphism / no mutation detected | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| tBRCA variant description | BRCA1 and BRCA2 variants detected by Myriad myChoice HRD (location and type of mutation) will be described. | Baseline |
Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria: Aged 20 years or older of Japanese women at the time of consent (the age of death, in case of dead patient)
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This is a Japanese, multi-center, observational study. Patients with newly diagnosed FIGO stage III - IV OC after 1st January, 2019 will be enrolled sequentially.
Patients those who have undergone or are planning to undergo BRACAnalysis, which detects BRCA mutations, are eligible for this study. 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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Matsuyama | Ehime | Japan | |||
| Research Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials/studies via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| The prevalence of sBRCAm in the subjects |
For BRCA1 and BRCA2 mutations detected by BRACAnalysis and Myriad myChoice HRD, the number and percentage of patients with the following results will be indicated; deleterious mutation / suspected deleterious |
| Baseline |
| The ratio of sBRCAm out of tBRCAm | Calculate the rate of sBRCAm out of tBRCAm | Baseline |
| 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 |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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