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
Recruiting now
Conditions studied: Breast Neoplasm
In brief
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.
Key facts
- Study ID
- NCT06672302
- Run by
- EXoPERT
- People needed
- 330
- Starts
- 2024-10-16
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-01-08
Who can join
Age: 40 and older. Sex: female. Healthy volunteers: not accepted.
You may not qualify if…
- Those who have been diagnosed with cancer (malignant tumor) of any type within 5 years of the date of consent and have undergone appropriate chemotherapy/radiation treatment or surgery.
- Those who are confirmed to have developed breast cancer due to metastasis from malignant tumors other than breast cancer
- Pregnant women
- Participation in a drug-related clinical trial within 3 months of the date of the informed consent form
Where it is running
- Korea University Anam Hospital — Seoul, South Korea (enrolling)
- Korea University Guro Hospital — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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