Autoantibodies in Breast Cancer Detection

Stopped early

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT03623945

Run by

Sanford Health

People needed

1279

Starts

2018-07-24

Expected to finish

2024-03-11

Last updated by the study team

2024-12-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sanford Health — Fargo, North Dakota, United States
• Sanford Health — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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