Genetic Characteristics of Metastatic Breast Cancer Patients

NCT ID: NCT04258735

Last Updated: 2020-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-17

Study Completion Date

2024-07-31

Brief Summary

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Genomic analysis for metastatic breast cancer(MBC) patients

* Participant (Inclusion criteria)

1. Patients who diagnosed metastatic/stage IV breast cancer
2. Patients who were not received treatment for metastatic breast cancer on palliative setting
* 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.

Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Metastatic breast cancer cohort

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

Group Type OTHER

Genomic analysis

Intervention Type DIAGNOSTIC_TEST

WES, RNASeq, ctDNA, Exosome

Interventions

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Genomic analysis

WES, RNASeq, ctDNA, Exosome

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients who did not agree this study
* Patients who did not have any pathologic specimen at MBC diagnosis.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Young-Hyuck Im

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Young-Hyuck Im, MD,PhD

Role: CONTACT

82-2-3410-3459

Ji-Yeon Kim, MD

Role: CONTACT

82-2-3410-3459

Facility Contacts

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Young-Hyuck Im, MD, PhD

Role: primary

+82-2-3410-3445

Other Identifiers

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2019-05-157

Identifier Type: -

Identifier Source: org_study_id

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