NCT04258735

Brief Summary

Genomic analysis for metastatic breast cancer(MBC) patients

  • Process (1) Tissue/ Blood sample
  • At diagnosis, MBC tissue / blood sample (20cc) will be obtained.
  • At disease progression after 1st line treatment for MBC, blood sample (20cc) will be obtained (tissue; optional) (2) WES, RNASeq, ctDNA, Exosome
  • We will analyze genomic characteritics using WES, RNASeq, ctDNA, Exosome.

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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

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

July 17, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

5 years

First QC Date

July 23, 2019

Last Update Submit

February 5, 2020

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Genomic profiling of MBC patients

    Gemetic alteration frequency, the association between genetic alteration and survival

    60 months

Study Arms (1)

Metastatic breast cancer cohort

OTHER

Metastatic breast cancer with genetic tests including WES, RNASeq, ctDNA and exosome

Diagnostic Test: Genomic analysis

Interventions

Genomic analysisDIAGNOSTIC_TEST

WES, RNASeq, ctDNA, Exosome

Metastatic breast cancer cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who diagnosed ad metastatic breast cancer
  • Patients who were not received treatment on palliative setting

You may not qualify if:

  • Patients who did not agree this study
  • Patients who did not have any pathologic specimen at MBC diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Young-Hyuck Im, MD,PhD

CONTACT

82-2-3410-3459yh00.im@samsung.com

Ji-Yeon Kim, MD

CONTACT

82-2-3410-3459jyeon25.kim@samsung.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 23, 2019

First Posted

February 6, 2020

Study Start

July 17, 2019

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

February 6, 2020

Record last verified: 2020-02

Locations

KR(1)