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
| NCT ID | NCT06672302 |
| Status | Recruiting |
| Phase | — |
| Sponsor | EXoPERT |
| Condition | Breast Neoplasm |
| Study Type | OBSERVATIONAL |
| Enrollment | 330 participants |
| Start Date | 2024-10-16 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 330 participants in total. It began in 2024-10-16 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06672302 clinical trial?
This trial is open to female participants only, aged 40 Years or older, studying Breast Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06672302 currently recruiting?
Yes, NCT06672302 is actively recruiting participants. Contact the research team at necain1003@exopert.com for enrollment information.
Where is the NCT06672302 trial being conducted?
This trial is being conducted at Honolulu, United States, Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT06672302 clinical trial?
NCT06672302 is sponsored by EXoPERT. The trial plans to enroll 330 participants.