MedTrace Logo

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

NCT06672302 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 330

Last updated 2026-01-08

No results posted yet for this study

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.

Conditions

  • Breast Neoplasm

Interventions

DIAGNOSTIC_TEST

ExoPred

Performing in vitro diagnostics with devices developed by EXoPERT

Sponsors & Collaborators

  • EXoPERT

    lead INDUSTRY

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-16
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06672302 on ClinicalTrials.gov