Blood test to identify patients at high risk for breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Korea University Anam Hospital
  Seoul, South Korea Recruiting
• Korea University Guro Hospital
  Seoul, South Korea Recruiting
• Univercity of Hawaii Cancer Center
  Honolulu, Hawaii, United States Not yet recruiting

Study contacts

• Study coordinator: Jongwon Choi
• Email: necain1003@exopert.com
• Phone: +82-10-3931-2941

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.