Testing BRCA 1/2 Mutation Using Next Generation Sequencing | NCT02151747

Studies
Testing BRCA 1/2 Mutation Using Next Generation Sequencing

NCT02151747

Sponsor

Severance Hospital

Status

Completed

Last Update Posted

Oct 7, 2019Actual

Enrollment

12Actual

Phase

Not provided

Conditions

Breast Neoplasms
Breast Cancer

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

May 28, 2014

First Submission Date that Met QC Criteria

May 29, 2014

First Posted Date

May 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2019

Last Update Posted Date

Oct 7, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sanger		BRCA 1/2 test results by Sanger sequencing
NGS		BRCA 1/2 test results by NGS

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Accuracy	after enrollment, comparison between Sanger and NGS method will be performed.	1 year

Secondary Outcomes

Measure	Description	Time Frame
Sensitivity, Specificity	Sensitivity and specificity of NGS	1 year

Other Outcomes

Measure	Description	Time Frame
False negative and false positive rates	False negative and false positive rates of NGS	1 year

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with breast cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yonsei University College of Medicine		Seoul		120-752	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided