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Completed

NCT Number: NCT02151747

Testing BRCA 1/2 Mutation Using Next Generation Sequencing

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.

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Key information

Conditions

Breast Neoplasms Breast Cancer Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall Accuracy

    Time frame: 1 year

    after enrollment, comparison between Sanger and NGS method will be performed.

Secondary outcomes

  1. Sensitivity, Specificity

    Time frame: 1 year

    Sensitivity and specificity of NGS

Other outcomes

  1. False negative and false positive rates

    Time frame: 1 year

    False negative and false positive rates of NGS

Sponsors and collaborators

Lead sponsor

Severance Hospital

Other

Registry information

Official study title

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

Acronym: BRCANGS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 30, 2014
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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