Autoantibodies in Breast Cancer Detection



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/11/2018
Start Date:July 24, 2018
End Date:July 1, 2022
Contact:Jenna Hove, RN BSN
Email:jenna.hove@sanfordhealth.org
Phone:605-312-3337

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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
We found this trial at
2
sites
Fargo, North Dakota 58122
Principal Investigator: Kristi Egland, PhD
Phone: 701-234-7258
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Fargo, ND
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Sioux Falls, South Dakota 57104
Principal Investigator: Kristi Egland, PhD
Phone: 605-312-3325
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Sioux Falls, SD
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