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

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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.


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
12
sites
Sioux Falls, South Dakota 57105
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Sioux Falls, SD
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Providence, RI
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Berkeley Heights, New Jersey 07922
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Berkeley Heights, NJ
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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Detroit, Michigan 48235
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Detroit, MI
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Oklahoma City, Oklahoma 73120
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Oklahoma City, OK
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350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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Phoenix, AZ
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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Sacramento, California 95816
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Sacramento, CA
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San Diego, California 92037
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San Diego, CA
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Scottsdale, Arizona 85259
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Scottsdale, AZ
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