Testing BRCA 1/2 Mutation Using Next Generation Sequencing

Breast Cancer Clinical Trial

— BRCANGS  

Official title:

Pilot Study of Validation of Testing BRCA 1/2 Mutation Using Next Generation Sequencing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02151747
• Other study ID #: 4-2013-0889
• Status: Completed
• Start date: February 2014
• Est. completion date: February 2015

Study information

• Verified date: October 2019
• Source: Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Testing BRCA 1/2 mutation is important for patients with breast cancer, and Sanger sequencing is a standard method to identify BRCA 1/2 mutation. Next generation sequencing (NGS) is a high-throughput parallel sequencing that can provide genetic information with high accuracy. NGS is a faster and cost-effective method to detect gene mutations compared to Sanger sequencing. In this study, we evaluated the clinical role of NGS testing for BRCA 1/2 compared to Sanger sequencing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age > 18

• Breast or ovarian cancer history in 2nd degree family members

• Male breast cancer

• Bilateral breast cancer

• Patient with breast cancer under 40 year of age

• Simultaneous breast and ovarian cancer

• Patients with epithelial ovarian cancer

• Breast cancer with other simultaneous extramammary malignancy

Exclusion Criteria:

-Patients who do not agree with testing BRCA 1/2 mutation

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	False negative and false positive rates	False negative and false positive rates of NGS	1 year
Primary	Overall Accuracy	after enrollment, comparison between Sanger and NGS method will be performed.	1 year
Secondary	Sensitivity, Specificity	Sensitivity and specificity of NGS	1 year

External Links

•   Poster number OT2-4-02