Breast Cancer
Conditions
Brief 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.
Interventions
OTHERCollection of blood
Collection of blood only to look at circulating autoantibodies that recognize breast cancer proteins to potentially be used as a biosensor for identifying patients with increased risk of having breast cancer
Sponsors
Inanovate
Sanford Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Autoantibodies for breast cancer diagnosis | 5 years | The data from Phase I will be tested and validated with newly diagnosed BCa patient samples from Cohort A, and age-matched healthy controls taken from Cohort D, and a risk score will be developed based on a composite of autoantibodies for breast cancer diagnosis. A Cox Proportional Hazards (PH) Regression will be used to analyze a case-cohort study design to validate the risk score by identifying breast cancer cases from those cases in Cohorts B, C and D. |
Countries
United States
Outcome results
None listed