Blood test to identify patients at high risk for breast cancer
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
This study is testing a new blood test that uses advanced technology to see if it can help identify women at high risk for breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 330 (estimated) |
| Ages | 40 Years and up |
| Sex | Female |
| Sponsor | EXoPERT Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT06672302 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to develop and validate a blood-based diagnostic device that classifies patients as high or low risk for breast cancer using Raman spectroscopy and artificial intelligence. The device analyzes extracellular vesicles in blood samples to assist in the differential diagnosis of breast cancer risk. By confirming the clinical efficacy and safety of this device, the study seeks to improve early detection and diagnosis of breast cancer, which is crucial for effective treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adult females aged 40 and older who have been diagnosed with breast cancer and fall into BI-RADS categories 4, 5, or 6.
Not a fit: Patients who do not have breast cancer or those who are younger than 40 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could lead to earlier and more accurate identification of patients at high risk for breast cancer, potentially improving treatment outcomes.
How similar studies have performed: Other studies utilizing liquid biopsy and AI for cancer diagnosis have shown promise, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul and 1 other locations
- Korea University Anam Hospital — Seoul, South Korea (Recruiting)
- Korea University Guro Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Jongwon Choi
- Email: necain1003@exopert.com
- Phone: +82-10-3931-2941
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.