Exosome as the Prognostic and Predictive Biomarker in EBC Patients

Sponsor

Samsung Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05955521

Collaborator

(none)

200

Enrollment

Location

Arm

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Triple Negative Breast Cancer HER2-positive Breast Cancer	Procedure: exosome and ctDNA evaluation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

May 1, 2021

Actual Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CtDNA/Exosome evaluation	Procedure: exosome and ctDNA evaluation Serial exosome and ctDNA evaluation during follow up period between neoadjuvant chemotherapy and surveillance after curative surgery.

Arm

Intervention/Treatment

Experimental: CtDNA/Exosome evaluation

Procedure: exosome and ctDNA evaluation

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

Outcome Measures

Primary Outcome Measures

Prognostic biomarker for EBC [60 months]
Positive predictive value of ctDNA/Exosome for BC recurrence

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ji-Yeon Kim	Seoul		Korea, Republic of	06351

Sponsors and Collaborators

Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

JI-YEON, KIM, Professor, Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT05955521

Other Study ID Numbers:

EXO_Breast

First Posted:

Jul 21, 2023

Last Update Posted:

Jul 21, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Triple Negative Breast Neoplasms

Study Results

No Results Posted as of Jul 21, 2023