RecruitingNCT06672302

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

A Multi-center, Single Arm, Prospective Exploratory in Vitro Diagnostic Devices Clinical Performance Study to Evaluate of in Vitro Diagnostic Devices for Auxiliary Diagnosis That Classifies High-risk and Low Risk Patients With Breast Cancer by Analyzing Surface-enhanced Raman Spectroscopy (SERS) Profiles of Extracellular Vesicles (EVs) Extracted From Human Plasma Using Artificial Intelligence

Sponsor

EXoPERT

Enrollment

330 participants

Start Date

Oct 16, 2024

Study Type

OBSERVATIONAL

Conditions

Breast Neoplasm

Summary

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.

Eligibility

Sex: FEMALEMin Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is developing and testing a blood-based diagnostic tool designed to identify women at high risk for breast cancer. The goal is to create a simple blood test that could help detect breast cancer risk earlier and with less invasive methods than current imaging techniques. **You may be eligible if...** - You are a Korean woman aged 40 or older - You have confirmed breast cancer through imaging or pathology (prior to treatment) - Your breast imaging results fall into certain risk categories (BI-RADS 4, 5, or 6) - You have had or are scheduled for a biopsy - You are willing to provide a blood sample **You may NOT be eligible if...** - You have already begun treatment or surgery for breast cancer - You are unwilling to provide required clinical information or blood samples - You do not meet the age or nationality requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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