Breast Cancer Biomarker Sample Collection for the dtectDx v2 Assay Proof of Concept Protocol
- Conditions
- Breast Cancer
- Registration Number
- NCT02078570
- Lead Sponsor
- Provista Diagnostics, Inc
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 500
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Modified Quantitative Protein Algorithmic Score (QPAS) 6 Months 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.
Quantitative Protein Algorithmic Score (QPAS) Baseline 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
- Secondary Outcome Measures
Name Time Method QPAS relative to BI-RADS Baseline 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.
Trial Locations
- Locations (12)
Avera Research Institute
🇺🇸Sioux Falls, South Dakota, United States
Summit Medical Group Breast Center New Jersey
🇺🇸Berkeley Heights, New Jersey, United States
Scripps
🇺🇸San Diego, California, United States
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
Mercy Womens Center
🇺🇸Oklahoma City, Oklahoma, United States
St. Joseph's Hospital & Medical Center
🇺🇸Phoenix, Arizona, United States
Sutter Institute
🇺🇸Sacramento, California, United States
Sinai Grace
🇺🇸Detroit, Michigan, United States
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States