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RECRUITING

NCT06672302

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

Sponsor: EXoPERT

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

40 Years - Any

Study Type

OBSERVATIONAL

Enrollment

330

Start Date

2024-10-16

Completion Date

2026-12-31

Last Updated

2026-09-10

Healthy Volunteers

Conditions

Breast Neoplasm

Interventions

DIAGNOSTIC_TEST

ExoPred

Performing in vitro diagnostics with devices developed by EXoPERT

Inclusion Criteria(Breast malignant nodule group) 1. Korean nationality 2. Voluntary written consent to participate in this clinical performance trial study 3. Confirmed breast cancer through imaging/pathologic diagnostic tests 4. Those who have been diagnosed with breast cancer at a stage prior to treatment and surgery, and who agree to participate in this study and are able to provide blood samples. 5. Those whose lesions have been confirmed by conventional examination (breast ultrasound or mammography) and who fall into BI-RADS categories 4,5,6 and have undergone biopsy or are scheduled to undergo biopsy within 2 weeks. 6. Those who meet the following demographic conditions A. Adult female, 40 years of age or older 7. Those who can provide the following clinical information A. Age and biological sex B. Whether or not they have dense breasts C. Occupational information D. Pathological tumor size, Clinical tumor size, Pathological TNM staging, Clinical TNM staging, tumor location, breast cancer histology findings (breast cancer subtype) E. Family history and past history of cancer F. Breast-related diseases G. Chronic disease history Inclusion Criteria(Breast benign nodule group) 1. Korean nationality 2. Voluntary written consent to participate in this clinical performance trial study 3. Diagnosed with breast nodules through imaging/pathologic diagnostic tests 4. Those who have been diagnosed with breast nodules and have agreed to participate in this study and are able to provide blood samples at a stage prior to treatment and surgery. 5. Those whose lesions have been confirmed by conventional examination (breast ultrasound or mammography) and fall into BI-RADS categories 4,5,6 and have undergone biopsy or are scheduled for biopsy within 2 weeks 6. Those who meet the following demographic conditions A. Adult female, 40 years of age or older 7. Those who can provide the following clinical information A. Age and biological sex B. Whether or not they have dense breasts C. Occupational information D. Diagnosis, nodule size, and number of nodules E. Family history and past history of cancer F. Breast-related diseases G. Chronic disease history Exclusion Criteria: 1. 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. 2. Those who are confirmed to have developed breast cancer due to metastasis from malignant tumors other than breast cancer 3. Pregnant women 4. Participation in a drug-related clinical trial within 3 months of the date of the informed consent form

Locations (3)

Univercity of Hawaii Cancer Center

Honolulu, Hawaii, United States

Korea University Anam Hospital

Seoul, South Korea

Korea University Guro Hospital