Breast Cancer Clinical Trial
Autoantibodies in Breast Cancer Detection
Summary
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. We are no longer enrolling women who had normal Screening mammograms.
Eligibility Criteria
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
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