Patients with newly diagnosed (at the first diagnosis of) FIGO stage III - IV ovarian cancer (OC)
Conditions
Interventions
None listed
Sponsors
AstraZeneca K.K.
Linical Co.,Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Aged 20 years or older of Japanese women at the time of consent (the age of death, in case of dead patient) 2.Newly diagnosed as advanced OC (FIGO stage III - IV) with epithelial ovarian cancer, primary peritoneal cancer or fallopian-tube cancer [or a combination thereof] after January 1, 2019 3.Patients who have archived formalin-fixed paraffin-embedded (FFPE) samples of primary or peritoneal metastatic tumor collected after January 1, 2019 4.Patients who have performed BRACAnalysis or who are going to be diagnosed by it 5.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
Exclusion criteria: 1.Patients who are not recommended enrolling this study decided by study investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) / favor polymorphism / no mutation detected | — |
Secondary
| Measure | Time frame |
|---|---|
| <Secondary Endpoints> 1.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) / favor polymorphism / no mutation detected 2.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 3.The rate of sBRCAm out of tBRCAm <Exploratory Endpoints> 1.BRCA1 and BRCA2 variants detected by Myriad myChoice HRD (location and type of mutation) 2.HRD score; positive / negative 3.BRCA1/2 and HRD score detected by Myriad myChoice HRD will be classified as follows; Age, Menopausal status, Cancer type, Histological classification (central pathologist reviewing), FIGO stage, medical history, Family history of cancer, History of smoking | — |
Countries
Japan
Contacts
Public ContactMika Kanno
Linical Co.,Ltd. Contract Medical Affairs Unit, Clinical Trial Operations
Outcome results
None listed