Blood test: Proprietary immunogenomic signature from peripheral blood CD14 and CD2 cells.
Study summary
Differential immunogenomic signatures from peripheral blood CD14 (phagocytic) and CD2 (non-phagocytic) cells have been associated with multiple cancers and disease states. In particular several large clinical studies at Immunis.AI have demonstrated robust immunogenomic signatures in early-stage prostate cancer. Immunis.AI therefore hypothesizes that a peripheral blood immunogenomic signature will identify patients with various stages of breast cancer from healthy negative controls.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients \> 18 yrs of age.
* Patients diagnosed with stage I-IV breast cancer, who have not begun definitive therapy.
* Patients undergoing screening mammograms for breast cancer.
Exclusion Criteria:
* Patients with a history of a different cancer within the previous 3 years (except non melanoma skin cancer).
* Any prior treatment (surgery, chemo, hormonal, radiation, biologics, etc.) for current cancer.
* Any biopsy which resulted in the entire tumor tissue being removed.
* History of previous breast cancer.
* Patients unable to provide informed consent.
* Patients with an abnormal screening mammogram.
* Patients whose hormone receptor and/or HER2 status are not available.
Primary outcome measure(s)
Primary Aim — 12 months To determine if differential gene expression between peripheral blood phagocytic and non-phagocytic immune cells can distinguish breast cancer patients from cancer-negative controls.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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