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

Tracking Information

First Received Date ^ICMJE

January 6, 2008

Last Updated Date

May 9, 2011

Start Date ^ICMJE

November 2007

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Find out the prevalence of BRCA1/2 mutation of high risk breast cancer patients [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00595348 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Korean Hereditary Breast Cancer Study

Official Title ^ICMJE

Korean Hereditary Breast Cancer Study

Brief Summary

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.

Detailed Description

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

DNA, Serum, plasma, Whole blood

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Breast Cancer
Ovarian Cancer

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

2250

Estimated Completion Date

May 2017

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Ku Sang Kim, M.D, AME.

82-31-219-5200

ideakims@gmail.com

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00595348

Other Study ID Numbers ^ICMJE

KBCSG003, Sung-Won Kim, brca@korea.com

Has Data Monitoring Committee

Yes

Responsible Party

Sung-Won Kim, Seoul National University Bundang Hospital, Surgery

Study Sponsor ^ICMJE

Korean Breast Cancer Study Group

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

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

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

Information Provided By

Korean Breast Cancer Study Group

Verification Date

May 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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