Ignite Creation Date:
2024-05-06 @ 2:07 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04222465
Status:
COMPLETED
Last Update Posted:
2021-10-26
First Post:
2020-01-07
Brief Title:
Characterizing the Cross-sectional Approach to Investigate the Prevalence of Tissue BRCA12 Mutations in Newly Diagnosed Advanced Ovarian Cancer Patients
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Characterizing the Cross-sectional Approach to Investigate the Prevalence of Tissue BRCA12 Mutations in Newly Diagnosed Advanced Ovarian Cancer Patients
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHRISTELLE
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
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 designThis 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 populationPatients with FIGO stage III - IV epithelial ovarian cancer Drug exposureNot applicable Planned study sites and sample sizeThe objective number of patients will be 200 from approximately 20 hospitals
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 populationPatients with FIGO stage III - IV epithelial ovarian cancer Drug exposureNot applicable Planned study sites and sample sizeThe objective number of patients will be 200 from approximately 20 hospitals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None