NCT05955521

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
May 2021Jul 2028

Study Start

First participant enrolled

May 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Expected
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

2.2 years

First QC Date

July 13, 2023

Last Update Submit

July 13, 2023

Conditions

Triple Negative Breast CancerHER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Prognostic biomarker for EBC

    Positive predictive value of ctDNA/Exosome for BC recurrence

    60 months

Study Arms (1)

CtDNA/Exosome evaluation

EXPERIMENTAL
Procedure: exosome and ctDNA evaluation

Interventions

exosome and ctDNA evaluationPROCEDURE

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

CtDNA/Exosome evaluation

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Early breast cancer
  • Planned neoadjuvant chemotherapy
  • Triple negative breast cancer or HER2-positive breast cancer

You may not qualify if:

  • Stage IV breast cancer
  • Hormone receptor positive breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ji-Yeon Kim

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2023

First Posted

July 21, 2023

Study Start

May 1, 2021

Primary Completion

July 1, 2023

Study Completion (Estimated)

July 1, 2028

Last Updated

July 21, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)