Back to resultsExosome as the Prognostic and Predictive Biomarker in EBC Patients
Primary Purpose
Triple Negative Breast Cancer, HER2-positive Breast Cancer
Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
exosome and ctDNA evaluation
Sponsored by
About this trial
This is an interventional screening trial for Triple Negative Breast Cancer
Eligibility Criteria
Inclusion Criteria: Early breast cancer Planned neoadjuvant chemotherapy Triple negative breast cancer or HER2-positive breast cancer Exclusion Criteria: Stage IV breast cancer Hormone receptor positive breast cancer
Sites / Locations
- Ji-Yeon Kim
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CtDNA/Exosome evaluation
Arm Description
Outcomes
Primary Outcome Measures
Prognostic biomarker for EBC
Positive predictive value of ctDNA/Exosome for BC recurrence
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05955521
Brief Title
Exosome as the Prognostic and Predictive Biomarker in EBC Patients
Official Title
Development of a Prognostic and Predictive Biomarker for Locally Advanced Breast Cancer Patients Treated With Neoadjuvant Chemotherapy Using Exosome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2028 (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
This study is the experimental study for serial ctDNA and exosome evaluation in EBC patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer, HER2-positive Breast Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CtDNA/Exosome evaluation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
exosome and ctDNA evaluation
Intervention Description
Serial exosome and ctDNA evaluation during follow up period between neoadjuvant chemotherapy and surveillance after curative surgery.
Primary Outcome Measure Information:
Title
Prognostic biomarker for EBC
Description
Positive predictive value of ctDNA/Exosome for BC recurrence
Time Frame
60 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Early breast cancer
Planned neoadjuvant chemotherapy
Triple negative breast cancer or HER2-positive breast cancer
Exclusion Criteria:
Stage IV breast cancer
Hormone receptor positive breast cancer
Facility Information:
Facility Name
Ji-Yeon Kim
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exosome as the Prognostic and Predictive Biomarker in EBC Patients
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