Breast Cancer Clinical Trial
Official title:
Blood Test for Early Detection of Breast Cancer Using Todos Medical -Breast 1(TM-B1) Assay
Blood samples from a total of 200 women in two cohorts will be collected and analyzed by TM-B1 assay, which is based on TBIA (Total Biochemical Infrared Analysis) to confirm the presence of cancer. These two cohorts will yield 75 healthy women with no pathological findings, 75 women diagnosed as having benign breast tumor and 50 women diagnosed as having breast cancer.
Prospective, two arms, observational, blinded, cohort study enrolling 200 women which
intended to validate the cut-off points between women with malignant tumors, benign tumors,
and women without tumors (controls) and to validate the sensitivity and specificity of TM-B1
for the detection of an invasive breast tumor.
Two cohorts will be tested with TM-B1. The cohorts will differ in the percentage of women
that are expected to yield a positive finding for breast cancer. Any finding in TM-B1 will
not influence medical standards of care.
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