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Korean Hereditary Breast Cancer Study (KOHBRA)

This study is currently recruiting participants.
Verified May 2011 by Korean Breast Cancer Study Group
Sponsor:
Information provided by:
Korean Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00595348
First received: January 6, 2008
Last updated: May 9, 2011
Last verified: May 2011
History of Changes
  Purpose
  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.

Condition
Breast Cancer
Ovarian Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Korean Hereditary Breast Cancer Study

Resource links provided by NLM:

U.S. FDA Resources

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: 6 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

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:
  1. To find founder mutation in Korean
  2. To correlation prevalence with risk evaluation
  3. 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: Ku Sang Kim, M.D, AME. 82-31-219-5200 ideakims@gmail.com

Locations
Korea, Republic of
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

No publications provided by Korean Breast Cancer Study Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sung-Won Kim, Seoul National University Bundang Hospital, Surgery
ClinicalTrials.gov Identifier: NCT00595348     History of Changes
Other Study ID Numbers: KBCSG003, Sung-Won Kim, brca@korea.com
Study First Received: January 6, 2008
Last Updated: May 9, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Ovarian Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
 Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on May 19, 2013