NCT02151747

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

October 7, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

May 28, 2014

Last Update Submit

October 3, 2019

Conditions

Breast NeoplasmsBreast Cancer

Keywords

breast neoplasms, BRCA1, Sanger, NGS, Next generation sequencing

Outcome Measures

Primary Outcomes (1)

  • Overall Accuracy

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

    1 year

Secondary Outcomes (1)

  • Sensitivity, Specificity

    1 year

Other Outcomes (1)

  • False negative and false positive rates

    1 year

Study Arms (2)

Sanger

BRCA 1/2 test results by Sanger sequencing

NGS

BRCA 1/2 test results by NGS

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with breast cancer

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Seung IL Kim, MD, phD

    Yonsei University

    STUDY DIRECTOR

  • JH Sohn, MD,phD

    Yonsei University

    STUDY DIRECTOR

  • Hyung Seok Park, MD

    Yonsei University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

May 28, 2014

First Posted

May 30, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

October 7, 2019

Record last verified: 2019-10

Locations

KR(1)