Actively Recruiting
A Prospective Study to Develop and Clinically Validate an in Vitro Diagnostic Medical Device That Uses Blood to Classify Patients at High Risk for Breast Cancer
Led by EXoPERT · Updated on 2026-01-08
330
Participants Needed
2
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
EXoPERT has developed a liquid biopsy-based in vitro diagnostic medical device that can diagnose cancer through blood. The in vitro diagnostic medical device for this clinical performance trial is a test device that applies a technology that measures Raman spectroscopic signals of extracellular vesicles in the blood and classifies high-risk and low-risk patients for breast cancer through artificial intelligence analysis. The test device used in this clinical performance trial is expected to assist in the differential diagnosis of high-risk and low-risk breast cancer patients by developing a software algorithm for an in vitro diagnostic medical device for auxiliary diagnosis that classifies high-risk and low-risk breast cancer patients and confirming the clinical efficacy and safety of the device through this clinical performance trial.
CONDITIONS
Official Title
A Prospective Study to Develop and Clinically Validate an in Vitro Diagnostic Medical Device That Uses Blood to Classify Patients at High Risk for Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Korean nationality
- Voluntary written consent to participate in this clinical performance trial study
- Confirmed breast cancer through imaging/pathologic diagnostic tests
- Diagnosed with breast cancer or breast nodules prior to treatment and surgery
- Lesions confirmed by breast ultrasound or mammography and classified as BI-RADS categories 4, 5, or 6
- Biopsy performed or scheduled within 2 weeks
- Adult female, 40 years of age or older
- Able to provide clinical information including age, sex, breast density, occupational info, tumor/nodule details, family and medical history
You will not qualify if you...
- Diagnosed with any cancer and treated with chemotherapy, radiation, or surgery within the past 5 years
- Breast cancer caused by metastasis from other malignant tumors
- Pregnant women
- Participation in a drug-related clinical trial within 3 months prior to consent
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Korea University Anam Hospital
Seoul, South Korea
Actively Recruiting
2
Korea University Guro Hospital
Seoul, South Korea
Actively Recruiting
Research Team
J
Jongwon Choi
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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