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NCT04258735 Clinical Trial

Genetic Characteristics of Metastatic Breast Cancer Patients

Metastatic Breast Cancer Clinical Trial

Official title:
Genetic Characteristics of Metastatic Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04258735
Other study ID # 2019-05-157
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 17, 2019
Est. completion date July 31, 2024

Study information
Verified date February 2020
Source Samsung Medical Center
Contact Young-Hyuck Im, MD,PhD
Phone 82-2-3410-3459
Email yh00.im@samsung.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Genomic analysis
WES, RNASeq, ctDNA, Exosome

Locations
Country Name City State
Korea, Republic of Samsung Medical Center, Sungkyunkwan University School of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Genomic profiling of MBC patients Gemetic alteration frequency, the association between genetic alteration and survival 60 months
See also
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