Breast CancerKOHBRANCT00595348
Korean Hereditary Breast Cancer Study
An observational study of Breast Cancer and Ovarian Cancer, run by Korean Breast Cancer Study Group at 1 site in South Korea.
Trial summary
1. To evaluate the prevalence of BRCA1/2 mutation of breast cancer patients with family history of breast/ovarian cancer. 2. To evaluate the prevalence of BRCA1/2 mutation of breast cancer patients without family history, but high risk of hereditary cancer. 3. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Ovarian Cancer
- How many people
- 2,250 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2007to May 2017
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All Medical Center including personal breast clinic, general hospital, university hospital, cancer institute in Korea
Who may be able to join
- Over 19 years old
- Agree to this study
- Breast cancer patient with family history of breast/ovarian cancer (1 subgroup)
- Breast cancer patient; young age (<40), bilateral, male, combined ovarian (2 subgroup)
- Family members with 1, 2 subgroups (3 subgroup)
Who cannot join
- Under 20 years old
- Unable to decide for oneself
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Surgery, Breast & Endocrine Service Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Sung-Won Kim, M.D.,Ph.D., 82-31-787-7094, brca@korea.com
About this study
- To evaluate the prevalence of BRCA1/2 mutation of breast cancer patients with family history of breast/ovarian cancer.
- To evaluate the prevalence of BRCA1/2 mutation of breast cancer patients without family history, but high risk of hereditary cancer.
- To evaluate the prevalence of BRCA1/2 mutation of family member of BRCA1/2 mutation.
- To evaluate the prevalence of ovarian cancer of population of above 3 groups.
Read the detailed description
- To find founder mutation in Korean
- To correlation prevalence with risk evaluation
- To find risk factors concerning life style
- Conditions
- Breast Cancer, Ovarian Cancer
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Find out the prevalence of BRCA1/2 mutation of high risk breast cancer patients
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionMay 2012 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean Breast Cancer Study Group
- Sponsor type
- University, hospital or other
- Investigators
- Sung-Won Kim, M.D, Ph.D., Principal investigator, Department of Surgery, Breast & Endocrine Service, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595348
- Sponsor's protocol ID
- KBCSG003
- Other IDs
- Sung-Won Kim, brca@korea.com
- Acronym
- KOHBRA
- Status last verified
- May 2011
- First submitted
- 6 Jan 2008
- Last updated
- 11 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ko KP, Kim SW, Ma SH, Park B, Ahn Y, Lee JW, Lee MH, Kang E, Kim LS, Jung Y, Cho YU, Lee B, Lin JH, Park SK. Dietary intake and breast cancer among carriers and noncarriers of BRCA mutations in the Korean Hereditary Breast Cancer Study. Am J Clin Nutr. 2013 Dec;98(6):1493-501. doi: 10.3945/ajcn.112.057760. Epub 2013 Oct 23.
PubMed 24153343Han SA, Kim SW, Kang E, Park SK, Ahn SH, Lee MH, Nam SJ, Han W, Bae YT, Kim HA, Cho YU, Chang MC, Paik NS, Hwang KT, Kim SJ, Noh DY, Choi DH, Noh WC, Kim LS, Kim KS, Suh YJ, Lee JE, Jung Y, Moon BI, Yang JH, Son BH, Yom CK, Kim SY, Lee H, Jung SH; KOHBRA Research Group and the Korean Breast Cancer Society. The prevalence of BRCA mutations among familial breast cancer patients in Korea: results of the Korean Hereditary Breast Cancer study. Fam Cancer. 2013 Mar;12(1):75-81. doi: 10.1007/s10689-012-9578-7.
PubMed 23131904Han SA, Park SK, Ahn SH, Lee MH, Noh DY, Kim LS, Noh WC, Jung Y, Kim KS, Kim SW; Korean Breast Cancer Study Group. The Korean Hereditary Breast Cancer (KOHBRA) study: protocols and interim report. Clin Oncol (R Coll Radiol). 2011 Sep;23(7):434-41. doi: 10.1016/j.clon.2010.11.007. Epub 2011 Apr 16.
PubMed 21497495
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korean Hereditary Breast Cancer Study
- ClinicalTrials.gov ID
- NCT00595348
- Acronym / sponsor ID
- KOHBRA / KBCSG003
- Conditions
- Breast Cancer, Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,250 participants (estimated)
- Lead sponsor
- Korean Breast Cancer Study GroupUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 16 Jan 2008 (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.
- To evaluate the prevalence of BRCA1/2 mutation of breast cancer patients with family history of breast/ovarian cancer.
- To evaluate the prevalence of BRCA1/2 mutation of breast cancer patients without family history, but high risk of hereditary cancer.
- To evaluate the prevalence of BRCA1/2 mutation of family member of BRCA1/2 mutation.
- To evaluate the prevalence of ovarian cancer of population of above 3 groups.
Detailed description
- To find founder mutation in Korean
- To correlation prevalence with risk evaluation
- To find risk factors concerning life style
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All Medical Center including personal breast clinic, general hospital, university hospital, cancer institute in Korea
Key inclusion criteria (5 listed)
- Over 19 years old
- Agree to this study
- Breast cancer patient with family history of breast/ovarian cancer (1 subgroup)
- Breast cancer patient; young age (<40), bilateral, male, combined ovarian (2 subgroup)
- Family members with 1, 2 subgroups (3 subgroup)
Key exclusion criteria (2 listed)
- Under 20 years old
- Unable to decide for oneself
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
Find out the prevalence of BRCA1/2 mutation of high risk breast cancer patients
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2011.
- Derived from this study: PubMed 24153343Ko KP, Kim SW, Ma SH, Park B, Ahn Y, Lee JW, Lee MH, Kang E, Kim LS, Jung Y, Cho YU, Lee B, Lin JH, Park SK. Dietary intake and breast cancer among carriers and noncarriers of BRCA mutations in the Korean Hereditary Breast Cancer Study. Am J Clin Nutr. 2013 Dec;98(6):1493-501. doi: 10.3945/ajcn.112.057760. Epub 2013 Oct 23.
- Derived from this study: PubMed 23131904Han SA, Kim SW, Kang E, Park SK, Ahn SH, Lee MH, Nam SJ, Han W, Bae YT, Kim HA, Cho YU, Chang MC, Paik NS, Hwang KT, Kim SJ, Noh DY, Choi DH, Noh WC, Kim LS, Kim KS, Suh YJ, Lee JE, Jung Y, Moon BI, Yang JH, Son BH, Yom CK, Kim SY, Lee H, Jung SH; KOHBRA Research Group and the Korean Breast Cancer Society. The prevalence of BRCA mutations among familial breast cancer patients in Korea: results of the Korean Hereditary Breast Cancer study. Fam Cancer. 2013 Mar;12(1):75-81. doi: 10.1007/s10689-012-9578-7.
- Derived from this study: PubMed 21497495Han SA, Park SK, Ahn SH, Lee MH, Noh DY, Kim LS, Noh WC, Jung Y, Kim KS, Kim SW; Korean Breast Cancer Study Group. The Korean Hereditary Breast Cancer (KOHBRA) study: protocols and interim report. Clin Oncol (R Coll Radiol). 2011 Sep;23(7):434-41. doi: 10.1016/j.clon.2010.11.007. Epub 2011 Apr 16.
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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.
Sung-Won Kim, M.D, Ph.D. principal investigator
Department of Surgery, Breast & Endocrine Service, Seoul National University Bundang Hospital
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 Cancer and Ovarian Cancer, run by Korean Breast Cancer Study Group 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 May 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ku Sang Kim, M.D, AME. (82-31-219-5200, ideakims@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Find out the prevalence of BRCA1/2 mutation of high risk breast cancer patients (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00595348, which also lists 3 linked publications.
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 11 May 2011.