Study to Assess Prevalence of BRCA1 and BRCA2 Mutation Among Ovarian, Primary Peritoneal and Fallopian Tube Cancer Patients in India

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT03471572
• Lead Sponsor: AstraZeneca

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 breast/ovarian cancer, current and previous chemotherapy regimen and current medication will be collected.

Study Timeline

• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-14
• Study First Posted: 2018-03-20
• Study Start: 2018-03-22
• Primary Completion: 2018-12-21
• Study Completion: 2018-12-21
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

1. Patients who provide written informed consent
2. Female ≥ 18 years of age
3. Previously or newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer patients.

Exclusion Criteria

1. Patient with any medical condition that, in the opinion of the investigator, would interfere with safe completion of the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BRCA1 or BRCA2 mutation positive status	1 day	ENIGMA (Evidence-based Network for the Interpretation of Germline Mutant Alleles)

Secondary Outcome Measures

Name	Time	Method
Association between histopathological type and BRCA 1/BRCA 2 mutation positive status	1 Day	Frequency of different histopathological type and BRCA 1/BRCA 2 mutation positive status will be presented.

Trial Locations

Locations (1)

Research Site; 🇮🇳 Kolkata, West Bengal, India