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

Status:	Active, not recruiting
Conditions:	Breast Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	25 - 75
Updated:	4/21/2016
Start Date:	March 2014

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.

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.

We found this trial at

sites

St. Joseph's Hospital and Medical Center

350 W Thomas Rd
Phoenix, Arizona 85013

(602) 406-3000