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Study identifier: NCT06672302 Synced from ClinicalTrials.gov · July 28, 2026
● 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

Condition: Breast Neoplasm  ·  Sponsor: EXoPERT

PhaseN/A
Planned participants330
Who can joinFemale, 40 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Jongwon Choi  ·  +82-10-3931-2941  ·  necain1003@exopert.com

Always discuss trial participation with your own doctor first.

Locations (2)

Korea University Anam HospitalSeoul, South KoreaRecruiting
Korea University Guro HospitalSeoul, South KoreaRecruiting

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Source record: clinicaltrials.gov/study/NCT06672302