1. Elevated risk population sub-group: Women at elevated risk undergoing routine screening for breast cancer.
A. Asymptomatic Screening Inclusion Criteria
- Age ≥ 30 and ≤ 75
- Planned MRI (for women who qualify) and/or planned screening mammogram (and/or breast ultrasound)
- Presentation of factor(s) indicating elevated risk for breast cancer development
o Factors may include germline genetic mutations known to increase risk of breast cancer, very dense (D) breast tissue, family history, and/or clinical risk assessment and scoring at elevated risk (20% or greater lifetime risk, or 3% or greater 10-year risk assessed at age 40, using the Tyrer-Cuzick model (v.7 or v.8) or 1.67% or greater 5-year breast cancer risk using the BCSC model
- Willing and able to give Written Informed Consent and provide a whole blood sample
Exclusion Criteria
- Physical breast symptoms or concerns
- Current or suspected cancer diagnosis
- Prior BI-RADS 3 or higher imaging results in last 12 months
- Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy) within the last 12 months
- Previous history of any cancer, except for non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma)
- Previous history of invasive or non-invasive breast cancer
- Concomitant or other concurrent anti-cancer therapy
- Blood transfusions within the past 3 months
- Born biologically male
B. Recall Inclusion Criteria
- Age ≥ 30 and ≤ 75
- Previous MRI (for women who qualify) and/or screening mammogram (and/or breast ultrasound) indicating follow-up imaging or biopsy recommended
- Presentation of factor(s) indicating elevated risk for breast cancer development
o Factors may include germline genetic mutations known to increase risk of breast cancer, very dense (D) breast tissue, family history, and/or clinical risk assessment and scoring at elevated risk (20% or greater lifetime risk, or 3% or greater 10-year risk assessed at age 40, using the Tyrer-Cuzick model (v.7 or v.8) or BOADICEA v6.0 or 1.67% or greater 5-year breast cancer risk using the BCSC model.
- Willing and able to give Written Informed Consent and provide a whole blood sample
Exclusion Criteria
- Physical breast symptoms or concerns
- Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy) within the last 12 months
- Current diagnosis or history of any cancer, including DCIS, with the exception of non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma)
- Blood transfusions within the past 3 months
- Born biologically male
2. Recall (Secondary care) Symptomatic population: Women recommended for follow-up due to physical symptoms. This includes recommendation for diagnostic imaging and/or biopsy due to physical symptoms.
Inclusion Criteria
- Age ≥ 30 and ≤ 75
- Planned diagnostic breast imaging (mammogram, breast MRI and/or breast ultrasound) and/or breast biopsy, as recall or follow-up from prior examination or to evaluate breast symptom.
- Willing and able to give Written Informed Consent and provide a whole blood sample.
Exclusion Criteria
- Current known cancer diagnosis
- Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy) within the last 12 months
- History of any cancer, with the exception of non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma)
- Blood transfusions within the past 3 months
- Born biologically male
3. Asymptomatic average, low or unknown risk population: Women undergoing routine screening for breast cancer. Women in the Screening population would have no physical symptoms and be consented near the time of a screening imaging session (within 3 months). Recruitment may also occur after a screening imaging session with a recommendation for follow-up imaging, or after diagnostic imaging with a recommendation for a biopsy as part of the recall population.
Inclusion Criteria
- Age ≥ 30 and ≤ 75
- Screening mammogram and/or breast ultrasound, breast MRI within 3 months
- Willing and able to give Written Informed Consent and provide a whole blood sample
Exclusion Criteria
- Physical breast symptoms or concerns
- Breast surgery within the previous 12 months (for any reason) or breast biopsy (including needle core biopsy) within the last 12 months
- History of any cancer, including DCIS, with the exception of non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma)
- Blood transfusions within the past 3 months
- Born biologically male