Clinical trial NCT00595348: Korean Hereditary Breast Cancer Study
Official title: Korean Hereditary Breast Cancer Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Ovarian Cancer
Lead sponsor: Korean Breast Cancer Study Group
Sponsor class: OTHER
First posted: 2008-01-16
Enrollment: 2250
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Medical Center including personal breast clinic, general hospital, university hospital, cancer institute in Korea

Brief 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. To evaluate the prevalence of BRCA1/2 mutation of family member of BRCA1/2 mutation.
4. To evaluate the prevalence of ovarian cancer of population of above 3 groups.

Detailed description: 1. To find founder mutation in Korean
2. To correlation prevalence with risk evaluation
3. To find risk factors concerning life style

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Under 20 years old
* Unable to decide for oneself

Primary outcomes:
measure: Find out the prevalence of BRCA1/2 mutation of high risk breast cancer patients
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-Si
country: Korea, Republic of
facility: Department of Surgery, Breast & Endocrine Service Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Department of Surgery, Breast & Endocrine Service, Seoul National University Bundang Hospital
name: Sung-Won Kim, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Han 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.
citation: Han 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.