Abstract
BackgroundBladder cancer (BC) is the 5th most common cancer in the USA. Non-muscle invasive bladder cancer represents about 70% of all cases and has generally a favorable outcome. However, recurrence rates as high as 60 to 70% and progression rates of 10 to 20% necessitate intensive surveillance with cystoscopy. The invasiveness and high cost of cystoscopy poses significant burden on BC patients as well as on the healthcare system. In this study we test the feasibility of a simple, sensitive, and non-invasive detection of BC using Bladder CARE test in urine samples.ResultsUrine from 136 healthy and 77 BC subjects was collected using the at-home Bladder CARE Urine Collection Kit and analyzed with Bladder CARE test. The test measures the methylation level of three BC-specific biomarkers and two internal controls using methylation-sensitive restriction enzymes coupled with qPCR. Bladder CARE showed an overall sensitivity of 93.5%, a specificity of 92.6%, and a PPV and NPV of 87.8% and 96.2%, respectively. Bladder CARE has an LOD as low as 0.046%, which equates to detecting 1 cancer cell for every 2,200 cells analyzed. We also provided evidence that bisulfite-free methods to assess DNA methylation, like Bladder CARE, are advantageous compared to conventional methods that rely on bisulfite conversion of the DNA.ConclusionHighly sensitive detection of BC in urine samples is possible using Bladder CARE. The low LOD of the test and the measurement of epigenetic biomarkers make Bladder CARE a good candidate for the early detection of BC and possibly for the routine screening and surveillance of BC patients. Bladder CARE and the at-home urine sample collection system have the potential to (1) reduce unnecessary invasive testing for BC (2) reduce the burden of surveillance on patients and on the healthcare system, (3) improve the detection of early stage BC, and (4) allow physicians to streamline the monitoring of patients.
Highlights
IntroductionNon-muscle invasive bladder cancer represents about 70% of all cases and has generally a favorable outcome
Bladder cancer (BC) is the 5th most common cancer in the USA
In this study we evaluated the feasibility of Bladder CARE (Pangea Laboratory LLC, CA, USA) in the detection of BC in urine samples
Summary
Non-muscle invasive bladder cancer represents about 70% of all cases and has generally a favorable outcome. Recurrence rates as high as 60 to 70% and progression rates of 10 to 20% necessitate intensive surveillance with cystoscopy. The invasiveness and high cost of cystoscopy poses significant burden on BC patients as well as on the healthcare system. The most common histology is urothelial carcinoma; approximately 70% of all cases are non-muscle invasive bladder cancer (NMIBC), while the remaining 30% are represented by muscle invasive bladder cancer (MIBC) [10, 11]. Recurrence rates as high as 60 to 70% and progression rates of 10 to 20% necessitate intensive surveillance for NMIBC. While cystoscopy is the gold standard for the detection of bladder tumors, it is invasive, costly, and poses significant burden on the patient and on the healthcare system. The costs of treatment and surveillance make BC the most expensive cancer to manage [15]
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