The Study Objective is to evaluate the diagnostic efficacy of the liquid biopsy system versus the gold standard mammography (or MRI, or Ultrasound) diagnosis in patients with suspected breast cancer.
Women of the required age group, in case of suspicion of breast cancer, are sent to clarify the diagnosis for mammography or ultrasound of the mammary glands, or MRI. Based on the results of these studies, a biopsy is prescribed to make a final diagnosis. Before a biopsy to diagnose the presence / absence of breast cancer, patients do the blood sampling one time. The blood is processed in the Sponsor's laboratory. The test results are compared with the data obtained from the biopsy. The evaluation of the effectiveness of the method will be determined on the basis of the obtained data on the sensitivity and specificity of the test in relation to the reference method.
Study Type
OBSERVATIONAL
Enrollment
500
Women of the required age group, in case of suspicion of breast cancer, are sent to clarify the diagnosis for mammography or ultrasound of the mammary glands, or MRI. Based on the results of these studies, a biopsy is prescribed to make a final diagnosis. Before a biopsy to diagnose the presence / absence of breast cancer, patients do the blood sampling one time. The blood is processed in the Sponsor's laboratory. The test results are compared with the data obtained from the biopsy. The evaluation of the effectiveness of the method will be determined on the basis of the obtained data on the sensitivity and specificity of the test in relation to the reference method
Number of woman with positive ARNA Breast test confirmed by biopsy (Sensitivity)
Primary Measured Values for Efficiency Assessment: 1. the absolute total number of matches between the results of the test system and mammography based on histological confirmation of the diagnosis; 2. the sensitivity of the test by groups, particularly: the ratio of the number of true-positive test results to the total number of patients in the group with the presence of a character; 3. the specificity of the test by groups, particularly: the ratio of the number of true-negative test results to the total number of patients in the group with no character. A group of samples from patients with a confirmed diagnosis of breast cancer will be divided into 4 subgroups depending on the biological subtype of cancer identified on the basis of IHC analysis (luminal A, luminal B, HER2/neu, triple negative), also for the subgroups obtained the primary measured values will be calculated to identify these quantities based on the biological subtype of breast cancer.
Time frame: through study completion, an average of 1 year
Efficiency Evaluation
Estimation of the area under ROC-curve (AUC)
Time frame: through study completion, an average of 1 year
Relationship between test results and the age
Determination of a statistically significant relationship between test results and the age of patients at the time of testing
Time frame: through study completion, an average of 1 year
Positive predictive value
The ratio of true-positive test results to the total number of positive test results h) the ratio of true negative test results to the total number of negative test results (negative predictive value) i) Positive and negative likelihood ratio
Time frame: through study completion, an average of 1 year
Negative predictive value
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The ratio of true negative test results to the total number of negative test results
Time frame: through study completion, an average of 1 year