Young Breast Cancer Cohort Study | NCT03131089

Studies
Young Breast Cancer Cohort Study

NCT03131089

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Apr 27, 2017Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Breast 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

Status Module

Record Verification Date

Apr 2017

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

Apr 11, 2013Actual

Primary Completion Date

Feb 17, 2018Estimated

Completion Date

Apr 10, 2023Estimated

First Submitted Date

Apr 16, 2017

First Submission Date that Met QC Criteria

Apr 26, 2017

First Posted Date

Apr 27, 2017Actual

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

Apr 26, 2017

Last Update Posted Date

Apr 27, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

This study is prospective cohort study to investigate and identify comprehensively the clinicopathological features and long-term outcome of young breast cancer (YBC).

We have enrolled Breast cancer patients under 40 year-old and collected their baseline characteristics including tumor character, familiar history and other background information. Moreover, we have collected breast cancer tissue/blood sample for analyzing genetic characteristics, if patient agree to genetic analysis.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression free survival	Time to detect disease recurrence from surgery date	From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis with breast cancer
Age under 40 year-old or diagnosis with breast cancer at pregnancy or within 1year after delivery
Obtained informed consent form

Exclusion Criteria:

1) Cannot understand or disagree to informed consent form

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Diagnosis with breast cancer
Age under 40 year-old or diagnosis with breast cancer at pregnancy or within 1year after delivery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yeon Hee Park, MD	Contact	82-2-3410-1780		yhparkhmo@skku.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided