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

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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03471572

Acronym

BRCA

Enrollment

240

Registered

2018-03-20

Start date

2018-03-22

Completion date

2018-12-21

Last updated

2019-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

BRCA, ovarian cancer, fallopian tube cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 130 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

India

Outcome results