Korean Hereditary Breast Cancer Study | NCT00595348

Studies
Korean Hereditary Breast Cancer Study

NCT00595348

Sponsor

Korean Breast Cancer Study Group

Status

Unknown status

Last Update Posted

May 11, 2011Estimated

Enrollment

2,250Estimated

Phase

Not provided

Conditions

Breast Cancer
Ovarian Cancer

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Sung-Won Kim, brca@korea.com

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

May 2012Estimated

Completion Date

May 2017Estimated

First Submitted Date

Jan 6, 2008

First Submission Date that Met QC Criteria

Jan 15, 2008

First Posted Date

Jan 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2011

Last Update Posted Date

May 11, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,250Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Find out the prevalence of BRCA1/2 mutation of high risk breast cancer patients		6 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ku Sang Kim, M.D, AME.	Contact	82-31-219-5200		ideakims@gmail.com

Overall Officials

Name	Affiliation	Role
Sung-Won Kim, M.D, Ph.D.	Department of Surgery, Breast & Endocrine Service, Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery, Breast & Endocrine Service Seoul National University Bundang Hospital	Recruiting	Seongnam-si	Gyeonggi-do	463-707	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24153343	Derived	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.
23131904

ID	Term
D001943	Breast Neoplasms
D010051	Ovarian Neoplasms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases