ABCD: Autoantibodies in Breast Cancer Detection
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Other: 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. |
Other: 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). |
Other: 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. |
Other: 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
|
Outcome Measures
Primary Outcome Measures
- Autoantibodies for breast cancer diagnosis [5 years]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanford Health | Fargo | North Dakota | United States | 58104 |
| 2 | Sanford Health | Sioux Falls | South Dakota | United States | 57104 |
Sponsors and Collaborators
- Sanford Health
- Inanovate
Investigators
- Study Chair: Kristi Egland, PhD, Sanford Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SH ABCD