Korean Hereditary Breast Cancer Study

Breast Cancer Clinical Trial

— KOHBRA  

Official title:

Korean Hereditary Breast Cancer Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00595348
• Other study ID #: KBCSG003
• Secondary ID: Sung-Won Kim, br
• Status: Recruiting
• Phase: N/A
• First received: January 6, 2008
• Last updated: May 9, 2011
• Start date: November 2007
• Est. completion date: May 2017

Study information

• Verified date: May 2011
• Source: Korean Breast Cancer Study Group
• Contact: Ku Sang Kim, M.D, AME.
• Phone: 82-31-219-5200
• Email: ideakims[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical 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. 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.

Description:

1. To find founder mutation in Korean

2. To correlation prevalence with risk evaluation

3. To find risk factors concerning life style

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2250
• Est. completion date: May 2017
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Ovarian Cancer

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, Breast & Endocrine Service Seoul National University Bundang Hospital	Seongnam-Si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Korean Breast Cancer Study Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Find out the prevalence of BRCA1/2 mutation of high risk breast cancer patients		6 years	Yes