Korean Hereditary Breast Cancer Study - Full Text View

Korean Hereditary Breast Cancer Study (KOHBRA)

This study is currently recruiting participants.

Verified by Korean Breast Cancer Study Group, January 2008

Sponsored by:	Korean Breast Cancer Study Group
Information provided by:	Korean Breast Cancer Study Group
ClinicalTrials.gov Identifier:	NCT00595348

Purpose

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.

Condition
Breast Cancer Ovarian Cancer

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Ovarian Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Korean Hereditary Breast Cancer Study

Further study details as provided by Korean Breast Cancer Study Group:

Primary Outcome Measures:

Find out the prevalence of BRCA1/2 mutation of high risk breast cancer patients [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

DNA, Serum, plasma, Whole blood

Estimated Enrollment:	2250
Study Start Date:	November 2007
Estimated Study Completion Date:	May 2017
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Detailed Description:

To find founder mutation in Korean
To correlation prevalence with risk evaluation
To find risk factors concerning life style

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

All Medical Center including personal breast clinic, general hospital, university hospital, cancer institute in Korea

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595348

Contacts

Contact: Sung-Won Kim, M.D, Ph.D.

82-31-787-7094

brca@korea.com

Locations

Korea, Republic of, Gyeonggi-do
Department of Surgery, Breast & Endocrine Service Seoul National University Bundang Hospital	Recruiting
Seongnam-Si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Sung-Won Kim, M.D.,Ph.D. 82-31-787-7094 brca@korea.com

Sponsors and Collaborators

Korean Breast Cancer Study Group

Investigators

Principal Investigator:

Sung-Won Kim, M.D, Ph.D.

Department of Surgery, Breast & Endocrine Service, Seoul National University Bundang Hospital

More Information

Responsible Party:	Seoul National University Bundang Hospital, Surgery ( Sung-Won Kim )
Study ID Numbers:	KBCSG04, Sung-Won Kim, brca@korea.com
Study First Received:	January 6, 2008
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00595348
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Ovarian cancer
Ovarian Neoplasms
Skin Diseases
Gonadal Disorders
Genital Neoplasms, Female
Breast Neoplasms
Endocrine System Diseases

Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Endocrinopathy
Breast Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009