Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT06672302
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT06672302
Study Brief:
Protocol Section:
NCT06672302