Study to Assess Prevalence of BRCA1 and BRCA2 Mutation Among Ovarian, Primary Peritoneal and Fallopian Tube Cancer Patients in India
BRCA
A Non-interventional, Multicentre Study to Assess Prevalence of BRCA1 and BRCA2 Mutation Among Ovarian, Primary Peritoneal and Fallopian Tube Cancer Patients in India
1 other identifier
observational
240
1 country
8
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.
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 2018
Shorter than P25 for all trials
8 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
March 14, 2018
CompletedFirst Posted
Study publicly available on registry
March 20, 2018
CompletedStudy Start
First participant enrolled
March 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2018
CompletedDecember 18, 2019
December 1, 2019
9 months
March 14, 2018
December 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BRCA1 or BRCA2 mutation positive status
ENIGMA (Evidence-based Network for the Interpretation of Germline Mutant Alleles)
1 day
Secondary Outcomes (1)
Association between histopathological type and BRCA 1/BRCA 2 mutation positive status
1 Day
Study Arms (1)
1
Ovarian Cancer
Eligibility Criteria
Previously or newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer patients.
You may qualify if:
- Patients who provide written informed consent
- Female ≥ 18 years of age
- Previously or newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer patients.
You may not qualify if:
- \. Patient with any medical condition that, in the opinion of the investigator, would interfere with safe completion of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (8)
Research Site
Bangalore, Karnataka, 560027, India
Research Site
Mumbai, Maharashtra, 400012, India
Research Site
Mumbai, Maharashtra, 400071, India
Research Site
Delhi, New Delhi, 110005, India
Research Site
Delhi, New Delhi, 110017, India
Research Site
Delhi, New Delhi, 110060, India
Research Site
Hyderabad, Telangana, 500034, India
Research Site
Kolkata, West Bengal, 700099, India
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2018
First Posted
March 20, 2018
Study Start
March 22, 2018
Primary Completion
December 21, 2018
Study Completion
December 21, 2018
Last Updated
December 18, 2019
Record last verified: 2019-12