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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04222465

Acronym

CHRISTELLE

Enrollment

207

Registered

2020-01-10

Start date

2020-03-19

Completion date

2020-11-13

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Neoplasms

Keywords

Advanced ovarian cancer, BRCA1/2

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The prevalence of tBRCAm in the newly diagnosed advanced OC patients	Baseline	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

Secondary

Measure	Time frame	Description
The prevalence of gBRCAm in the subjects	Baseline	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
The prevalence of sBRCAm in the subjects	Baseline	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
The ratio of sBRCAm out of tBRCAm	Baseline	Calculate the rate of sBRCAm out of tBRCAm

Other

Measure	Time frame	Description
tBRCA variant description	Baseline	BRCA1 and BRCA2 variants detected by Myriad myChoice HRD (location and type of mutation) will be described.

Countries

Japan

Outcome results