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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

1550

Study ID:

NCT03623945

Recruitment Status:

Recruiting

Sponsor:

Sanford Health

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There are 2 Locations for this study

See Locations Near You

Sanford Health
Fargo North Dakota, 58104, United States More Info
Jennifer Rasmussen, RN
Contact
701-234-7258
[email protected]
Kristi Egland, PhD
Principal Investigator
Sanford Health
Sioux Falls South Dakota, 57104, United States More Info
Laurie Auch
Contact
605-312-3325
[email protected]
Kristi Egland, PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

1550

Study ID:

NCT03623945

Recruitment Status:

Recruiting

Sponsor:


Sanford Health

How clear is this clinincal trial information?

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