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Korean Hereditary Breast Cancer Study (KOHBRA)

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ClinicalTrials.gov Identifier: NCT00595348
Recruitment Status : Unknown
Verified May 2011 by Korean Breast Cancer Study Group.
Recruitment status was:  Recruiting
First Posted : January 16, 2008
Last Update Posted : May 11, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease
Breast Cancer Ovarian Cancer

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

Study Design

Study Type : Observational
Estimated Enrollment : 2250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Korean Hereditary Breast Cancer Study
Study Start Date : November 2007
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Find out the prevalence of BRCA1/2 mutation of high risk breast cancer patients [ Time Frame: 6 years ]

Biospecimen Retention:   Samples With DNA
DNA, Serum, plasma, Whole blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: May 11, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases