NCT00595348

Brief Summary

  1. 1.To evaluate the prevalence of BRCA1/2 mutation of breast cancer patients with family history of breast/ovarian cancer.
  2. 2.To evaluate the prevalence of BRCA1/2 mutation of breast cancer patients without family history, but high risk of hereditary cancer.
  3. 3.To evaluate the prevalence of BRCA1/2 mutation of family member of BRCA1/2 mutation.
  4. 4.To evaluate the prevalence of ovarian cancer of population of above 3 groups.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 11, 2011

Status Verified

May 1, 2011

Enrollment Period

4.5 years

First QC Date

January 6, 2008

Last Update Submit

May 9, 2011

Conditions

Breast CancerOvarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Find out the prevalence of BRCA1/2 mutation of high risk breast cancer patients

    6 years

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • Under 20 years old
  • Unable to decide for oneself

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

Related Publications (3)

  • Ko KP, Kim SW, Ma SH, Park B, Ahn Y, Lee JW, Lee MH, Kang E, Kim LS, Jung Y, Cho YU, Lee B, Lin JH, Park SK. Dietary intake and breast cancer among carriers and noncarriers of BRCA mutations in the Korean Hereditary Breast Cancer Study. Am J Clin Nutr. 2013 Dec;98(6):1493-501. doi: 10.3945/ajcn.112.057760. Epub 2013 Oct 23.

    PMID: 24153343DERIVED

  • Han SA, Kim SW, Kang E, Park SK, Ahn SH, Lee MH, Nam SJ, Han W, Bae YT, Kim HA, Cho YU, Chang MC, Paik NS, Hwang KT, Kim SJ, Noh DY, Choi DH, Noh WC, Kim LS, Kim KS, Suh YJ, Lee JE, Jung Y, Moon BI, Yang JH, Son BH, Yom CK, Kim SY, Lee H, Jung SH; KOHBRA Research Group and the Korean Breast Cancer Society. The prevalence of BRCA mutations among familial breast cancer patients in Korea: results of the Korean Hereditary Breast Cancer study. Fam Cancer. 2013 Mar;12(1):75-81. doi: 10.1007/s10689-012-9578-7.

    PMID: 23131904DERIVED

  • Han SA, Park SK, Ahn SH, Lee MH, Noh DY, Kim LS, Noh WC, Jung Y, Kim KS, Kim SW; Korean Breast Cancer Study Group. The Korean Hereditary Breast Cancer (KOHBRA) study: protocols and interim report. Clin Oncol (R Coll Radiol). 2011 Sep;23(7):434-41. doi: 10.1016/j.clon.2010.11.007. Epub 2011 Apr 16.

    PMID: 21497495DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA, Serum, plasma, Whole blood

MeSH Terms

Conditions

Breast NeoplasmsOvarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Sung-Won Kim, M.D, Ph.D.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ku Sang Kim, M.D, AME.

CONTACT

82-31-219-5200ideakims@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2008

First Posted

January 16, 2008

Study Start

November 1, 2007

Primary Completion

May 1, 2012

Study Completion

May 1, 2017

Last Updated

May 11, 2011

Record last verified: 2011-05

Locations

KR(1)