Characterizing the Cross-sectional Approach to Investigate the Prevalence of Tissue BRCA1/2 Mutations in Newly Diagnosed Advanced Ovarian Cancer Patients
CHRISTELLE
1 other identifier
observational
207
1 country
20
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Shorter than P25 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2020
CompletedFirst Posted
Study publicly available on registry
January 10, 2020
CompletedStudy Start
First participant enrolled
March 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2020
CompletedOctober 26, 2021
October 1, 2021
8 months
January 7, 2020
October 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
The prevalence of gBRCAm in the subjects
Baseline
The prevalence of sBRCAm in the subjects
Baseline
The ratio of sBRCAm out of tBRCAm
Baseline
Other Outcomes (1)
tBRCA variant description
Baseline
Eligibility Criteria
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.
You may qualify if:
- 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.)
You may not qualify if:
- Patients who are not recommended enrolling this study decided by physician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (20)
Research Site
Matsuyama, Ehime, Japan
Research Site
Tōon, Ehime, Japan
Research Site
Yoshida, Fukui, Japan
Research Site
Kitakyushu, Fukuoka, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Amagasaki, Hyōgo, Japan
Research Site
Kobe, Hyōgo, Japan
Research Site
Tsukuba, Ibaraki, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Kashihara, Nara, Japan
Research Site
Izumo, Shimane, Japan
Research Site
Bunkyo, Tokyo, Japan
Research Site
Minato, Tokyo, Japan
Research Site
Musashino, Tokyo, Japan
Research Site
Shinjuku, Tokyo, Japan
Research Site
Fukushima, Japan
Research Site
Gifu, Japan
Research Site
Kumamoto, Japan
Research Site
Niigata, Japan
Research Site
Yamagata, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2020
First Posted
January 10, 2020
Study Start
March 19, 2020
Primary Completion
November 13, 2020
Study Completion
November 13, 2020
Last Updated
October 26, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials/studies via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.