NCT03131089

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.

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
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

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

April 11, 2013

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2018

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2023

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

4.9 years

First QC Date

April 16, 2017

Last Update Submit

April 26, 2017

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

AgeUp to 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

1. Diagnosis with breast cancer 2. Age under 40 year-old or diagnosis with breast cancer at pregnancy or within 1year after delivery

You may qualify if:

  • 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

You may not qualify if:

  • \) Cannot understand or disagree to informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA from breast cancer tissue

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Yeon Hee Park, MD

CONTACT

82-2-3410-1780yhparkhmo@skku.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2017

First Posted

April 27, 2017

Study Start

April 11, 2013

Primary Completion

February 17, 2018

Study Completion

April 10, 2023

Last Updated

April 27, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)