Performance of MammoAlert™, Point of Care System, for the Screening of Breast Cancer in Women 18 Years of Age or Older

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multi-Centric Screening of Breast Cancer Patients to Determine Efficiency and to Assess Sensitivity & Accuracy of Pandora CDx MammoAlertTM in Screening of Breast Cancer.

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: MammoAlert Screening Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to give informed consent. Written informed consent by the patient/patient's legally acceptable representative (LAR) for donating blood sample Documented absence of cancer (other than Breast Cancer) Documented (Mammography and/or Biopsy) diagnosis of Breast Cancer (IDC/ILC/DCIS ), any stage Blood sample taken before any treatment for Breast Cancer was administered to the subject. Exclusion Criteria: Other malignancy besides breast cancer in the 5 years prior to obtaining the sample. Therapies for breast cancer that have been administered within 1 year of obtaining the sample Any condition (including psychiatric), which in the Investigator's opinion, places the patient at undue risk by participating in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Cancer Positive<br>A 5cc blood sample will be collected from subjects who were screened for breast cancer at the treating facility and results were positive. MammoAlert Screening Test will be performed on plasma obtained from the blood sample. | Other: MammoAlert Screening Test<br>* Plasma obtained from blood samples will be analyzed with the MammoAlert Screening Test for the presence of known breast cancer bio-markers.<br>|
| Breast Cancer Negative<br>A 5cc blood sample will be collected from subjects who were screened for breast cancer at the treating facility and results were negative. MammoAlert Screening Test will be performed on plasma obtained from the blood sample. | Other: MammoAlert Screening Test<br>* Plasma obtained from blood samples will be analyzed with the MammoAlert Screening Test for the presence of known breast cancer bio-markers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening performance (i.e., sensitivity and specificity) | Screening performance: comprises the sensitivity and specificity of MammoAlert™. It represents the performance of the diagnostic test and is therefore independent of the prevalence of the disease in the studied sample of patients. | Screening performance will be calculated at 4-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive values & likelihood ratios | Positive predictive value: the probability that a subject has the disease given that the test result is positive will be estimated by: TP/(TP+FP). Negative predictive value: the probability that a subject does not have the disease given that the result of the test is negative will be estimated by TN/(TN+FN). Likelihood ratio (LR): the likelihood that a given test result would be expected in a patient with the target disorder compared to the likelihood that that same result would be expected in a patient without the target disorder. | Predictive values & likelihood ratios will be calculated at 4-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Mammography