Back to resultsGenetic Characteristics of Metastatic Breast Cancer Patients
Primary Purpose
Metastatic Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Genomic analysis
Sponsored by
About this trial
This is an interventional health services research trial for Metastatic Breast Cancer
Eligibility Criteria
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.
Sites / Locations
- Samsung Medical Center, Sungkyunkwan University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Metastatic breast cancer cohort
Arm Description
Metastatic breast cancer with genetic tests including WES, RNASeq, ctDNA and exosome
Outcomes
Primary Outcome Measures
Genomic profiling of MBC patients
Gemetic alteration frequency, the association between genetic alteration and survival
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04258735
Brief Title
Genetic Characteristics of Metastatic Breast Cancer Patients
Official Title
Genetic Characteristics of Metastatic Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2019 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Genomic analysis for metastatic breast cancer(MBC) patients
Participant (Inclusion criteria)
Patients who diagnosed metastatic/stage IV breast cancer
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metastatic breast cancer cohort
Arm Type
Other
Arm Description
Metastatic breast cancer with genetic tests including WES, RNASeq, ctDNA and exosome
Intervention Type
Diagnostic Test
Intervention Name(s)
Genomic analysis
Intervention Description
WES, RNASeq, ctDNA, Exosome
Primary Outcome Measure Information:
Title
Genomic profiling of MBC patients
Description
Gemetic alteration frequency, the association between genetic alteration and survival
Time Frame
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young-Hyuck Im, MD,PhD
Phone
82-2-3410-3459
Email
yh00.im@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ji-Yeon Kim, MD
Phone
82-2-3410-3459
Email
jyeon25.kim@samsung.com
Facility Information:
Facility Name
Samsung Medical Center, Sungkyunkwan University School of Medicine
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Hyuck Im, MD, PhD
Phone
+82-2-3410-3445
Email
yh00.im@samsung.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Genetic Characteristics of Metastatic Breast Cancer Patients
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