Breast Cancer Clinical Trial
Official title:
Breast Cancer Biomarker Sample Collection for the DtectDx Assay Proof of Concept
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.
Status | Active, not recruiting |
Enrollment | 350 |
Est. completion date | August 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 49 Years |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Lahey Clinic | Peabody | Massachusetts |
United States | Banner Health | Phoenix | Arizona |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | Sutter Institute | Sacramento | California |
United States | Scripps | San Diego | California |
United States | Sansum Clinic | Santa Barbara | California |
United States | Avera Research Institute | Sioux Falls | South Dakota |
Lead Sponsor | Collaborator |
---|---|
Provista Diagnostics, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Training | Part I: Establish an acceptable algorithm for generation of a single numerical score from the combination of the 5 cancer biomarkers that comprise the dtectDX-Breast Assay Part II: Define a numerical score cutoff that differentiates malignant from nonmalignant breast cancer in this population of woman. | Baseline | No |
Primary | Blinded Validation | 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. | 6 months | No |
Secondary | Clinical Sensitivity/Specificity | Demonstrate the numerical score, collaborated via proprietary algorithm (greater then 60 is an elevated score, less then 60 is a normal score), for the dtectDx-Breast Assay 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. | Baseline | No |
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