Overview

This trial is active, not recruiting.

Condition breast cancer
Sponsor Provista Diagnostics, Inc
Start date March 2014
End date July 2017
Trial size 500 participants
Trial identifier NCT02078570, dtectDx-Breast-002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm

Primary Outcomes

Measure
Quantitative Protein Algorithmic Score (QPAS)
time frame: Baseline
Modified Quantitative Protein Algorithmic Score (QPAS)
time frame: 6 Months

Secondary Outcomes

Measure
QPAS relative to BI-RADS
time frame: Baseline

Eligibility Criteria

Female participants from 25 years up to 75 years old.

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.

Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Provista Diagnostics, Inc.