Breast Cancer Biomarker Sample Collection for the dtectDx v2 Assay Proof of Concept Protocol

Study Overview
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Brief Summary
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The major purpose of this study is to evaluate a laboratory developed test that measures multiple breast cancer-specific biomarker proteins and multiple antibodies in your blood samples. The biomarker and antibody results along with your personal medical profile will be evaluated to determine your risk for the presence of a malignancy in the breast as compared to your breast evaluation assessment conducted by your physician.

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult women from 25 years of age to below 75 years of age Breast evaluation results of ACR BI-RADS® Category 3 or 4 by imaging and physicians clinical and radiological evaluation Study visit and blood collection within 4 weeks (28 days) of ACR BI-RADS assessment Patient agrees to with additional health data being gathered at 6 months post assessment for diagnostic follow-up Samples collected under IRB approval and Informed Consent Testing performed under IRB approval or waiver (as applicable) Previous approved procedures to enroll patients: breast augmentation & cyst aspiration Exclusion Criteria: Adults from 76 years of age or older and below 25 years of age Final breast evaluation results other than a ACR BI-RADS Category 3 or 4 Subjects that have had a breast biopsy performed during the 6 months prior to the study visit Samples not collected under IRB approval and Informed Consent Testing not performed under IRB approval or waiver (as applicable) Prior breast cancer diagnosis.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Cancer ACR BI-RAD Category 3 or 4 result<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Protein Algorithmic Score (QPAS) | Part I: Establish an acceptable algorithm for the generation of a single numerical score from the combination of the 10 cancer biomarkers that comprise the dtectDx Breast v2.0 Assay Part II: Define a numerical score cutoff that differentiates malignant from nonmalignant breast cancer in this population of woman | Baseline | 
| Modified Quantitative Protein Algorithmic Score (QPAS) | Demonstrate proof-of-concept for use of the dtectDx-Breast Assay to assess likelihood of breast cancer malignancy in conjunction with the physicians clinical and radiological evaluations. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QPAS relative to BI-RADS | Demonstrate the numerical score, collaborated via proprietary algorithm , for the dtectDx-Breast Assay v2.0 increases the likelihood of malignant breast cancer detection when used adjunctively with the assessment of BI-RADS Categories 3 and 4 compared to the assessment of BI-RADS Categories 3 and 4 alone. | Baseline |