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Study closed to enrollment and data and specimen collection due to lack of funding.
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| Name | Class |
|---|---|
| Inanovate | UNKNOWN |
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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. We are no longer enrolling women who had normal Screening mammograms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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 |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of blood | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Autoantibodies for breast cancer diagnosis | 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. | 5 years |
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Inclusion Criteria:
All Cohorts:
Cohort A:
Cohort B:
Cohort C:
Cohort D:
• Normal screening mammogram within the last 6 months
Exclusion Criteria:
All Cohorts:
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:
Female patients only
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Women who have recently had an abnormal mammogram followed by a breast biopsy or women who have recently had a normal screening mammogram.
The study team will enroll approximately 1,550 participants at Sanford Health in Sioux Falls, SD and Fargo, ND. Cohort A= 300 participants, Cohort B= 250 participants, Cohort C= 500 participants and Cohort D= 500 participants.
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| Name | Affiliation | Role |
|---|---|---|
| Allison Watson, MD | Sanford Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanford Health | Fargo | North Dakota | 58104 | United States | ||
| Sanford Health |
No plan to share individual participant data
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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. |
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| Sioux Falls |
| South Dakota |
| 57104 |
| United States |
| D017437 |
| Skin and Connective Tissue Diseases |