Sioux Falls, South Dakota 57104


Purpose:

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


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


NCT ID:

NCT03623945


Primary Contact:

Study Chair
Kristi Egland, PhD
Sanford Health

Jenna Hove, RN BSN
Phone: 605-312-3337
Email: jenna.hove@sanfordhealth.org


Backup Contact:

N/A


Location Contact:

Sioux Falls, South Dakota 57104
United States

Laurie Auch
Phone: 605-312-3325
Email: laurie.auch@sanfordhealth.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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