Genetic Characteristics of Metastatic Breast Cancer Patients

February 5, 2020 updated by: Young-Hyuck Im, Samsung Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center, Sungkyunkwan University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Metastatic breast cancer cohort
Metastatic breast cancer with genetic tests including WES, RNASeq, ctDNA and exosome
Diagnostic test: Genomic analysis
WES, RNASeq, ctDNA, Exosome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genomic profiling of MBC patients
Time Frame: 60 months
Gemetic alteration frequency, the association between genetic alteration and survival
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2019

Primary Completion (Anticipated)

July 31, 2024

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

July 23, 2019

First Submitted That Met QC Criteria

February 5, 2020

First Posted (Actual)

February 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-05-157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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