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
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
330 participants
OBSERVATIONAL
2024-10-16
2026-12-31
Brief Summary
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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.
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Detailed Description
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Currently, breast cancer is diagnosed through breast ultrasound and mammography. These imaging modalities are defined by the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) to define the specificity and various characteristics of the lesion. BI-RADS is divided into six categories: Category 1 is no abnormality, Category 2 is a definite benign tumor, Category 3 is a high likelihood of benign tumor (≤2% positive predictive value), Category 4 is a low likelihood of malignancy (≤2% positive predictive value), except for Category 0, which is an incomplete determination, Category 4 is a moderate suspicion of malignancy (2\< positive predictive value \<95%), Category 5 is a very high probability of malignancy (positive predictive value ≥95%), and Category 6 is a pathologically diagnosed malignancy.
In the Breast Imaging Reporting and Data System (BI-RADS), biopsy is not required in category 3 because the likelihood of malignancy is 2% or less, so a 6-month follow-up is recommended, and biopsy is recommended starting from category 4A, where the frequency of malignancy is 3 - 10%. However, the BI-RADS criteria have a significant number of false-positive results, which leads to an increase in unnecessary biopsies. The need for complementary diagnostic tests that can overcome the limitations of conventional imaging tests and compensate for unnecessary biopsies is being emphasized.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Breast malignant nodule group
ExoPred
Performing in vitro diagnostics with devices developed by EXoPERT
Breast benign nodule group
ExoPred
Performing in vitro diagnostics with devices developed by EXoPERT
Interventions
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ExoPred
Performing in vitro diagnostics with devices developed by EXoPERT
Eligibility Criteria
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Inclusion Criteria
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
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
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
40 Years
FEMALE
No
Sponsors
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EXoPERT
INDUSTRY
Responsible Party
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Locations
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Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EXP-B-P-2401
Identifier Type: -
Identifier Source: org_study_id
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