Clinical trial NCT02078570: Breast Cancer Biomarker Sample Collection for the dtectDx v2 Assay Proof of Concept Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Provista Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2014-03-05
Enrollment: 500
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinics

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quantitative Protein Algorithmic Score (QPAS)
timeFrame: Baseline
measure: Modified Quantitative Protein Algorithmic Score (QPAS)
timeFrame: 6 Months
Secondary outcomes:
measure: QPAS relative to BI-RADS
timeFrame: Baseline
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital & Medical Center
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Sacramento
country: United States
facility: Sutter Institute
state: California
city: San Diego
country: United States
facility: Scripps
state: California
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Sinai Grace
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Berkeley Heights
country: United States
facility: Summit Medical Group Breast Center New Jersey
state: New Jersey
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: Mercy Womens Center
state: Oklahoma
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
Study officials:
References: