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

NCT06672302 | Recruiting

• 1 other identifier: EXP-B-P-2401
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Neoplasm

Keywords

Breast; Breast Cancer; Neoplasm

Outcome Measures

Primary Outcomes (2)

• Sensitivity

  through study completion, an average of 1 year

• Specificity

  through study completion, an average of 1 year

Study Arms (2)

Breast malignant nodule group

Diagnostic Test: ExoPred

Breast benign nodule group

Diagnostic Test: ExoPred

Interventions

ExoPred DIAGNOSTIC_TEST

Performing in vitro diagnostics with devices developed by EXoPERT

Breast benign nodule group; Breast malignant nodule group

Eligibility Criteria

• Age: 40 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients categorized as BI-RADS category 4,5,6

You may qualify if:

• Korean nationality
• Voluntary written consent to participate in this clinical performance trial study
• Confirmed breast cancer through imaging/pathologic diagnostic tests
• 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.
• 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.
• Those who meet the following demographic conditions A. Adult female, 40 years of age or older
• 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
• Korean nationality
• Voluntary written consent to participate in this clinical performance trial study
• Diagnosed with breast nodules through imaging/pathologic diagnostic tests
• 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.
• 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
• Those who meet the following demographic conditions A. Adult female, 40 years of age or older
• 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

You may not qualify if:

• 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.
• Those who are confirmed to have developed breast cancer due to metastasis from malignant tumors other than breast cancer
• Pregnant women
• Participation in a drug-related clinical trial within 3 months of the date of the informed consent form

Sponsors & Collaborators

• EXoPERT: lead

Study Sites (2)

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• Song SE, Shin H, Park Y, Choi Y, Jung SP. Artificial Intelligence-Based Exosome Analysis for Improving Diagnostic Performance of Breast Lesions on Ultrasound: Protocol of a Prospective, Multicenter Cohort Study. J Breast Cancer. 2026 Apr 1. doi: 10.4048/jbc.2025.0206. Online ahead of print.

  PMID: 41918185 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jongwon Choi

CONTACT

+82-10-3931-2941; necain1003@exopert.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: October 16, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

KR (2)