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

Ovarian Neoplasms Clinical Trial

— CHRISTELLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04222465
• Other study ID #: D0817R00018
• Status: Completed
• Start date: March 19, 2020
• Est. completion date: November 13, 2020

Study information

• Verified date: October 2021
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: November 13, 2020
• Est. primary completion date: November 13, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms

Locations

Country	Name	City	State
Japan	Research Site	Amagasaki	Hyogo
Japan	Research Site	Bunkyo	Tokyo
Japan	Research Site	Fukushima
Japan	Research Site	Gifu
Japan	Research Site	Izumo	Shimane
Japan	Research Site	Kashihara	Nara
Japan	Research Site	Kitakyushu	Fukuoka
Japan	Research Site	Kobe	Hyogo
Japan	Research Site	Kumamoto
Japan	Research Site	Matsuyama	Ehime
Japan	Research Site	Minato	Tokyo
Japan	Research Site	Musashino	Tokyo
Japan	Research Site	Niigata
Japan	Research Site	Sapporo	Hokkaido
Japan	Research Site	Sendai	Miyagi
Japan	Research Site	Shinjuku	Tokyo
Japan	Research Site	Toon	Ehime
Japan	Research Site	Tsukuba	Ibaraki
Japan	Research Site	Yamagata
Japan	Research Site	Yoshida	Fukui

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	tBRCA variant description	BRCA1 and BRCA2 variants detected by Myriad myChoice HRD (location and type of mutation) will be described.	Baseline
Primary	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
Secondary	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
Secondary	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
Secondary	The ratio of sBRCAm out of tBRCAm	Calculate the rate of sBRCAm out of tBRCAm	Baseline

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