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

POC Medical Systems

Status: Unknown

Conditions: Breast Cancer

Treatments: Other: MammoAlert Screening Test

Study type: Observational

Funder types: Industry

Identifiers

NCT03243877

POC-BC-0217

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,458 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ability to give informed consent. Written informed consent by the patient/patient's legally acceptable representative (LAR) for donating blood sample
2. Documented absence of cancer (other than Breast Cancer)
3. Documented (Mammography and/or Biopsy) diagnosis of Breast Cancer (IDC/ILC/DCIS ), any stage
4. Blood sample taken before any treatment for Breast Cancer was administered to the subject.

Exclusion criteria

1. Other malignancy besides breast cancer in the 5 years prior to obtaining the sample.
2. Therapies for breast cancer that have been administered within 1 year of obtaining the sample
3. Any condition (including psychiatric), which in the Investigator's opinion, places the patient at undue risk by participating in the study.

Trial design

2,458 participants in 2 patient groups

Breast Cancer Positive

Description:

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.

Treatment:

Other: MammoAlert Screening Test

Breast Cancer Negative

Description:

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.

Treatment:

Other: MammoAlert Screening Test