Breast Cancer Clinical Trial
Official title:
Multi-Centric Screening of Breast Cancer Patients to Determine Efficiency and to Assess Sensitivity & Accuracy of Pandora CDx MammoAlertTM in Screening of Breast Cancer.
POC Medical Systems has developed a Point of Care system for the screening of breast cancer in the general population. Via a proprietary algorithm, the MammoAlert™ is expected to determine breast cancer's risk level for a subject by identifying the presence in plasma of known biomarkers. The present study aims to determine the Sensitivity and Specificity of the test in plasma samples of subjects of whom the status vis-à-vis breast cancer is known.
2400 subjects will be screened for breast cancer in seven enrolling sites across the country
to ensure diverse ethnicity.
"Positive" subjects should be confirmed breast cancer positive by Mammography and/or biopsy.
Breast cancer positive samples will be compared to the control group of samples obtained from
women attending clinics for non-cancerous related pathology.
Both Positive and Negative Predictive Values will be evaluated to determine accuracy and
sensitivity of the screening test.
Subjects whose known cancer positive or negative status do not match the test report will be
followed up as appropriate, on case by case basis to identify false positive and false
negative results.
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