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

Status unconfirmed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02078570

Run by

Provista Diagnostics, Inc

People needed

500

Starts

2014-03-01

Last updated by the study team

2016-09-30

Who can join

Age: 25 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• St. Joseph's Hospital & Medical Center — Phoenix, Arizona, United States
• Mayo Clinic — Scottsdale, Arizona, United States
• Sutter Institute — Sacramento, California, United States
• Scripps — San Diego, California, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Sinai Grace — Detroit, Michigan, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Summit Medical Group Breast Center New Jersey — Berkeley Heights, New Jersey, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Mercy Womens Center — Oklahoma City, Oklahoma, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Avera Research Institute — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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