Breast Cancer Biomarker Sample Collection for the dtectDx Assay Verification

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 in your blood samples. The biomarker 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

NCT01839045

Run by

Provista Diagnostics, Inc

People needed

350

Starts

2013-03-01

Expected to finish

2014-08-01

Last updated by the study team

2014-06-09

Who can join

Age: 25 and older, up to 49. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Adult women from 25 years of age to below 50 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 3 weeks (21 days) of ACR BI-RADS assessment
• Patient agrees to return for diagnostic follow-up and blood collection at 6 months unless a positive cancer diagnosis is made between study visits 1 and 2. Individuals diagnosed with LCIS and DCIS will agree to return for visit 2
• Samples collected under IRB approval and Informed Consent
• Testing performed under IRB approval or waiver (as applicable)

You may not qualify if…

• Adults from 50 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 at any time 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

• Banner Health — Phoenix, Arizona, United States
• Sutter Institute — Sacramento, California, United States
• Scripps — San Diego, California, United States
• Sansum Clinic — Santa Barbara, California, United States
• Lahey Clinic — Peabody, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, 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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