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

Ovarian Cancer Clinical Trial

— BRCA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03471572
• Other study ID #: D0818R00001
• Status: Completed
• Start date: March 22, 2018
• Est. completion date: December 21, 2018

Study information

• Verified date: December 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 21, 2018
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
India	Research Site	Bangalore	Karnataka
India	Research Site	Delhi	New Delhi
India	Research Site	Delhi	New Delhi
India	Research Site	Delhi	New Delhi
India	Research Site	Hyderabad	Telangana
India	Research Site	Kolkata	West Bengal
India	Research Site	Mumbai	Maharashtra
India	Research Site	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BRCA1 or BRCA2 mutation positive status	ENIGMA (Evidence-based Network for the Interpretation of Germline Mutant Alleles)	1 day
Secondary	Association between histopathological type and BRCA 1/BRCA 2 mutation positive status	Frequency of different histopathological type and BRCA 1/BRCA 2 mutation positive status will be presented.	1 Day

External Links

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