Breast cancer is identified as the highest cause of death in women suffering from cancer. Early diagnosis is the key to increase the survival of breast cancer victims. Molecular diagnosis using biomarkers have advanced much in the recent years. The cost involved in such diagnosis is not affordable for most of the population. The concept being investigated here is to realize a simple diagnosis system for screening cancer by way of a blood test utilizing a miRNA based biomarker with a complementary molecular beacon probe. A microfluidic platform was designed and attached with a fluorescence reader, which is portable and cost effective. Experiments were performed with 51 blood samples of which 30 were healthy and 21 were positive for breast cancer, collected against institutional human ethical clearance, IHEC 16/180-7-9-2016. miRNA 21 was chosen as the biomarker because it is overexpressed 4-fold in the serum of breast cancer patients. This work involved design of an experiment to prove the concept of miRNA over expression followed by detection of miRNA 21 using the microfluidic platform attached with a fluorescence reader and validation of the results using quantitative Real Time Polymerase Chain Reaction (qRT-PCR). The results obtained from the microfluidic device concurred with qRT-PCR results. The device is suitable for point-of-care application in a mass-screening programme. The study also has revealed that the stage of the cancer could be indicated by this test, which will be further useful for deciding a therapeutic regime.
Diagnostic evaluation of suspected breast cancer due to abnormal screening mammography results is common, creates anxiety for women and is costly for the healthcare system. Timely evaluation with minimal use of additional diagnostic testing is key to minimizing anxiety and cost. In this paper we propose a Bayesian Semi-Markov model that allows for flexible, semi-parametric specification of the sojourn time distributions and apply our model to an investigation of the process of diagnostic evaluation with mammography, ultrasound and biopsy following an abnormal screening mammogram. We also investigate risk factors associated with the sojourn time between diagnostic tests. By utilizing Semi-Markov processes we expand on prior work which described the timing of the first test received by providing additional information such as the mean time to resolution and proportion of women with unresolved mammograms after 90 days for women requiring different sequences of tests in order to reach a definitive diagnosis. Overall, we found that older women were more likely to have unresolved positive mammograms after 90 days. Differences in the timing of imaging evaluation and biopsy were generally on the order of days and thus did not represent clinically important differences in diagnostic delay.
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