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NCT05955521 Clinical Trial

Exosome as the Prognostic and Predictive Biomarker in EBC Patients

Triple Negative Breast Cancer Clinical Trial

Official title:
Development of a Prognostic and Predictive Biomarker for Locally Advanced Breast Cancer Patients Treated With Neoadjuvant Chemotherapy Using Exosome

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05955521
Other study ID # EXO_Breast
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date July 1, 2028

Study information
Verified date July 2023
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is the experimental study for serial ctDNA and exosome evaluation in EBC patients

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 200
Est. completion date July 1, 2028
Est. primary completion date July 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• exosome and ctDNA evaluation
Serial exosome and ctDNA evaluation during follow up period between neoadjuvant chemotherapy and surveillance after curative surgery.

Locations
Country Name City State
Korea, Republic of Ji-Yeon Kim 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 Prognostic biomarker for EBC Positive predictive value of ctDNA/Exosome for BC recurrence 60 months
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