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

NCT04222465CompletedOBSERVATIONAL

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

Key Facts

Lead Sponsor

AstraZeneca

Enrollment

207

Start Date

2020-03-19

Completion Date

2020-11-13

Study Type

OBSERVATIONAL

Official Title

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

Conditions

Ovarian Neoplasms

Eligibility

Age Range

20 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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

Time frame: Baseline

Secondary Outcomes

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

Time frame: Baseline

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

Time frame: Baseline

The ratio of sBRCAm out of tBRCAm

Calculate the rate of sBRCAm out of tBRCAm

Time frame: Baseline

Locations

Research Site, Matsuyama, Japan

Research Site, Tōon, Japan

Research Site, Yoshida, Japan

Research Site, Kitakyushu, Japan

Research Site, Sapporo, Japan

Research Site, Amagasaki, Japan

Research Site, Kobe, Japan

Research Site, Tsukuba, Japan

Research Site, Sendai, Japan

Research Site, Kashihara, Japan

Research Site, Izumo, Japan

Research Site, Bunkyo, Japan

Research Site, Minato, Japan

Research Site, Musashino, Japan

Research Site, Shinjuku, Japan

Research Site, Fukushima, Japan

Research Site, Gifu, Japan

Research Site, Kumamoto, Japan

Research Site, Niigata, Japan

Research Site, Yamagata, Japan

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.

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