Inclusion Criteria:

- Adults 18 years of age or older

- Mentally competent and willing to provide written informed consent prior to entering
the study

- Military healthcare beneficiary

- Undergoing a diagnostic or therapeutic procedure (biopsy, lumpectomy, mastectomy) in
the breast clinic or operating room.

- Present to the CBCP and willing to be followed at the CBCP during the course of
treatment and follow-up

Exclusion Criteria:

- Prior history of invasive carcinoma

- Presence of clinically-apparent metastatic disease

- Participants with known human immunodeficiency virus (HIV), any history of hepatitis,
prion-mediated disease, drug resistant tuberculosis or other infectious disease
presenting a significant risk to personnel handling tissue or blood-derived products
shall be excluded from participation

- Participants with pre-existing coagulopathies or all other conditions, for whom
invasive biopsy or surgery is medically contraindicated