Breast NeoplasmsBRCANGSNCT02151747
Testing BRCA 1/2 Mutation Using Next Generation Sequencing
An observational study of Breast Neoplasms and Breast Cancer, run by Severance Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Breast Neoplasms, Breast Cancer
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast cancer
Who may be able to join
- 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
Who cannot join
- -Patients who do not agree with testing BRCA 1/2 mutation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Validation of 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.
- Conditions
- Breast Neoplasms, Breast Cancer
- Keywords
- breast neoplasms, BRCA1, Sanger, NGS, Next generation sequencing
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sanger | BRCA 1/2 test results by Sanger sequencing | |
| NGS | BRCA 1/2 test results by NGS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Accuracy
after enrollment, comparison between Sanger and NGS method will be performed.
Measured: 1 year
Secondary outcomes (1)
Sensitivity, Specificity
Sensitivity and specificity of NGS
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyung Seok Park, MD, PhD, Severance Hospital
- Investigators
- Seung IL Kim, MD, phD, Study director, Yonsei UniversityJH Sohn, MD,phD, Study director, Yonsei UniversityHyung Seok Park, MD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151747
- Sponsor's protocol ID
- 4-2013-0889
- Acronym
- BRCANGS
- Status last verified
- Oct 2019
- First submitted
- 28 May 2014
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Validation of Testing BRCA 1/2 Mutation Using Next Generation Sequencing
- ClinicalTrials.gov ID
- NCT02151747
- Acronym / sponsor ID
- BRCANGS / 4-2013-0889
- Conditions
- Breast Neoplasms, Breast Cancer
- Keywords
- breast neoplasms, BRCA1, Sanger, NGS, Next generation sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sanger | – | –BRCA 1/2 test results by Sanger sequencing |
| NGS | – | –BRCA 1/2 test results by NGS |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- -Patients who do not agree with testing BRCA 1/2 mutation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Accuracy
Time frame: 1 year
after enrollment, comparison between Sanger and NGS method will be performed.
1 secondary outcome
Sensitivity, Specificity
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung IL Kim, MD, phD study director
Yonsei University
JH Sohn, MD,phD study director
Yonsei University
Hyung Seok Park, MD principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Breast Cancer, run by Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Accuracy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019.