Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
1279 participants
OBSERVATIONAL
2018-07-24
2024-03-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A
Patients who have recently had an abnormal mammogram, followed by a breast biopsy and an initial diagnosis of Stage I, II, III or IV invasive breast cancer, will be invited to participate. Stage I, II and III participants will be further categorized into high-risk and low-risk. For the purposes of this study, participants with at least one of the following will be considered high-risk; any triple negative cancer, any grade III cancer, lymph node involvement, tumor greater than 2cm, or any patient receiving cytotoxic chemotherapy.
Collection 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
Cohort B
Patients who have recently had an abnormal mammogram, followed by a breast biopsy and diagnosed with a benign but high-risk pathology, will be invited to participate. This includes, but is not limited to, atypical ductal hyperplasia, atypical lobular hyperplasia, ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), flat epithelia atypia or phylloides.
Accrual to Cohort B is complete.
Collection 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
Cohort C
Patients who have recently had an abnormal mammogram, followed by a breast biopsy and diagnosed with a benign tumor, will be invited to participate. This includes, but is not limited to, fibroadenoma, papilloma, fibrocystic changes and Pseudoangiomatous stromal hyperplasia (PASH). Accrual to Cohort C is complete
Collection 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
Cohort D
Patients who have had a normal screening mammogram within the last 6 months will be invited to participate. Accrual to Cohort D is complete.
Collection 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
Cohort E
Patients who have recently had an abnormal mammogram, followed by a breast biopsy and an initial diagnosis of Stage I, II, III invasive breast cancer.
Patients who have recently had an abnormal mammogram, followed by a breast biopsy, and diagnosed with a benign but high-risk pathology.
Cohort E has 3 sub-groups. For the purposes of this study, participants with a breast cancer will be categorized as E1-malignant high risk, of E2-malignant low risk.
Patients who have recently had an abnormal mammogram, followed by a breast biopsy, and diagnosed with a benign but high-risk pathology, will be invited to participate.
These patients will be considered E3-benign high-risk.
Collection 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
Interventions
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Collection 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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Inanovate
UNKNOWN
Sanford Health
OTHER
Responsible Party
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Principal Investigators
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Allison Watson, MD
Role: PRINCIPAL_INVESTIGATOR
Sanford Health
Locations
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Sanford Health
Fargo, North Dakota, United States
Sanford Health
Sioux Falls, South Dakota, United States
Countries
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Other Identifiers
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SH ABCD
Identifier Type: -
Identifier Source: org_study_id