New blood test could revolutionize breast cancer screening

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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