- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06330870
Brain Metastasis Development Mechanism in BCBM Patients
March 19, 2024 updated by: JI-YEON, KIM, Samsung Medical Center
Evaluation of Brain Metastasis Development Mechanism in Patients With Breast Cancer With Brain Metastasis(BCBM)
This study is the experimental study for brain metastasis development mechanism in patients with breast cancer with brain metastasis
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ji-Yeon Kim
- Phone Number: 82-2-3410-3459
- Email: jyeon25@skku.edu
Study Contact Backup
- Name: Mee Ryung Hong
- Phone Number: 82-2-2148-7147
- Email: ring7629@naver.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 06351
- Recruiting
- Ji-Yeon Kim
-
Contact:
- Ji-Yeon Kim
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Breast cancer
- Brain metastasis curative surgery patient
Exclusion Criteria:
- Gamma Knife surgery patient
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: WGS/TME evaluation
This is not intervention clinical trial design.
We explore whole genome sequencing and tumor microenvironment evaluation for brain metastasis specimen in breast cancer patients.
|
WGS/TME evaluation with blood and brain metastasis tissue during brain metastasis curative surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intracranial disease free survival
Time Frame: Months
|
Time to new brain metastasis or brain metastasis progression from the brain surgery
|
Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 6, 2023
Primary Completion (Estimated)
February 5, 2025
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
February 6, 2024
First Submitted That Met QC Criteria
March 19, 2024
First Posted (Actual)
March 26, 2024
Study Record Updates
Last Update Posted (Actual)
March 26, 2024
Last Update Submitted That Met QC Criteria
March 19, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCBM_Breast
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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