Ignite Creation Date:
2024-05-06 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03471572
Status:
COMPLETED
Last Update Posted:
2019-12-18
First Post:
2018-03-14
Brief Title:
Study to Assess Prevalence of BRCA1 and BRCA2 Mutation Among Ovarian Primary Peritoneal and Fallopian Tube Cancer Patients in India
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Non-interventional Multicentre Study to Assess Prevalence of BRCA1 and BRCA2 Mutation Among Ovarian Primary Peritoneal and Fallopian Tube Cancer Patients in India
Status:
COMPLETED
Status Verified Date:
2019-12
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:
BRCA
Brief Summary:
This is a non-interventional cross-sectional multicentre observational study planned to be conducted at 15 sites across all geographical regions of India The study targets to enrol 240 patients with approximately 16 patients from each site Written approval of Independent Ethics Committee IEC Institutional Review Board IRB and written informed consent from willing patients will be obtained prior to the start of the study
Detailed Description:
This is a non-interventional cross-sectional multicentre observational study to be conducted at 15 sites from different geographical regions across India The study targets to enrol 240 patients with nearly 16 patients per site over 6 months The study will enrol females with diagnosis of ovarian primary peritoneal or fallopian tube cancer No study medication will be prescribed or administered as a part of study procedure
The study will start only after obtaining written approval of Independent Ethics Committee IEC Institutional Review Board IRB and written informed consent of the patient
The study will start only after obtaining written approval of Independent Ethics Committee IEC Institutional Review Board IRB and written informed consent of the patient Eligible patients will undergo physical examination and data of demographics vital signs present past history of illness family history of breastovarian cancer current and previous chemotherapy regimen and current medication will be collected
The study will start only after obtaining written approval of Independent Ethics Committee IEC Institutional Review Board IRB and written informed consent of the patient
The study will start only after obtaining written approval of Independent Ethics Committee IEC Institutional Review Board IRB and written informed consent of the patient Eligible patients will undergo physical examination and data of demographics vital signs present past history of illness family history of breastovarian cancer current and previous chemotherapy regimen and current medication will be collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None