Autoantibodies in Breast Cancer Detection
Autoantibodies in Breast Cancer Detection
Prospective, single-center study in women who have recently had an abnormal mammogram
 followed by a breast biopsy or women who have recently had a normal screening mammogram
Inclusion Criteria:

 -  Inclusion Criteria:

 All Cohorts:

 -  Women age 18 and older

 -  Understand and provide informed consent and HIPAA Authorization prior to initiation of
 any study-specific procedures

 Cohort A:

 -  Recent abnormal mammogram followed by a breast biopsy

 -  Initial diagnosis of Stage I, II, III or IV invasive breast cancer

 Cohort B:

 -  Recent abnormal mammogram followed by a breast biopsy

 -  Diagnosed benign breast tumor with high-risk pathology. This would include, but is not
 limited to, atypical ductal hyperplasia, atypical lobular hyperplasia, lobular
 carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), flat epithelia atypia and
 phylloides

 Cohort C:

 -  Recent abnormal mammogram followed by a breast biopsy

 -  Diagnosed benign breast tumor. This would include, but is not limited to,
 fibroadenoma, papilloma, fibrocystic changes, and Pseudoangiomatous stromal
 hyperplasia (PASH)

 Cohort D:

 • Normal screening mammogram within the last 6 months

 Exclusion Criteria:

 -  All Cohorts:

 -  Men.

 -  Unable or unwilling to give written informed consent

 Cohort A:

 • History of cancer other than non-melanoma basal or squamous cell skin carcinoma, ductal
 carcinoma in situ (DCIS) and cervical carcinoma in situ.

 Cohort B:

 • History of cancer other than non-melanoma basal or squamous cell skin carcinoma and
 cervical carcinoma in situ.

 Cohort C:

 • History of cancer other than non-melanoma basal or squamous cell skin carcinoma and
 cervical carcinoma in situ.

 Cohort D:

 -  History of cancer other than non-melanoma basal or squamous cell skin carcinoma and
 cervical carcinoma in situ.

 -  History of or current autoimmune disease including but not limited to Sjogrens
 Syndrome, Systemic Sclerosis (SSc), Scleroderma (Scl) and Dermatomyositis, Systemic
 Lupus Erythematosus, Multiple Sclerosis, Type I Diabetes, Rheumatoid Arthritis

 -  History of abnormal mammogram