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

Part of paid clinical trials in Honolulu, Hawaii.

Sponsor: EXoPERT
Study ID: NCT06672302
Status: Recruiting

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Conditions

Breast Neoplasm

Eligibility Criteria

Sex: FEMALE
Age: 40 Years - N/A
Healthy Volunteers: Not accepted

Interventions

ExoPred — DIAGNOSTIC_TEST
Performing in vitro diagnostics with devices developed by EXoPERT

Study Details

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.