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

Launched by EXOPERT · Oct 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new blood test designed to help identify women who are at high risk for breast cancer. The test works by analyzing tiny particles in the blood called extracellular vesicles using advanced technology. This innovative method aims to improve how doctors classify patients as either high-risk or low-risk for breast cancer, potentially leading to better and more personalized care.

To participate, women must be at least 40 years old, be Korean nationals, and willing to provide a blood sample. They should have either confirmed breast cancer or benign breast nodules that are being further examined. Participants will be asked to share some health information, such as their age, breast density, and any family history of cancer. Throughout the trial, women can expect to undergo standard diagnostic procedures, and their blood samples will be analyzed to determine how well this new test works. This study aims to confirm the safety and effectiveness of the test, which could ultimately help many women in the future.

Gender

FEMALE

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