Clinical trial NCT04222465: Characterizing the Cross-sectional Approach to Investigate the Prevalence of Tissue BRCA1/2 Mutations in Newly Diagnosed Advanced Ovarian Cancer Patients
Official title: Characterizing the Cross-sectional Approach to Investigate the Prevalence of Tissue BRCA1/2 Mutations in Newly Diagnosed Advanced Ovarian Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Neoplasms
Keywords: Advanced ovarian cancer, BRCA1/2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2020-01-10
Enrollment: 207
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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

Detailed 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.

Eligibility 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)
* 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

Primary outcomes:
measure: The prevalence of tBRCAm in the newly diagnosed advanced OC patients
timeFrame: Baseline
Secondary outcomes:
measure: The prevalence of gBRCAm in the subjects
timeFrame: Baseline
measure: The prevalence of sBRCAm in the subjects
timeFrame: Baseline
measure: The ratio of sBRCAm out of tBRCAm
timeFrame: Baseline
Other outcomes:
measure: tBRCA variant description
timeFrame: Baseline
Locations:
city: Matsuyama
country: Japan
facility: Research Site
state: Ehime
city: Toon
country: Japan
facility: Research Site
state: Ehime
city: Yoshida
country: Japan
facility: Research Site
state: Fukui
city: Kitakyushu
country: Japan
facility: Research Site
state: Fukuoka
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Amagasaki
country: Japan
facility: Research Site
state: Hyogo
city: Kobe
country: Japan
facility: Research Site
state: Hyogo
city: Tsukuba
country: Japan
facility: Research Site
state: Ibaraki
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Kashihara
country: Japan
facility: Research Site
state: Nara
city: Izumo
country: Japan
facility: Research Site
state: Shimane
city: Bunkyo
country: Japan
facility: Research Site
state: Tokyo
city: Minato
country: Japan
facility: Research Site
state: Tokyo
city: Musashino
country: Japan
facility: Research Site
state: Tokyo
city: Shinjuku
country: Japan
facility: Research Site
state: Tokyo
city: Fukushima
country: Japan
facility: Research Site
city: Gifu
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
Study officials:
References: