Development of a Peripheral Blood Test to Identify Invasive Bladder Cancer Using Standard Clinical Lab Equipment Development of a Peripheral Blood Test to Identify Invasive Bladder Cancer Using Standard Clinical Lab Equipment Urothelial cell carcinoma (UCC) of the urinary tract is one of the top ten causes of cancer deaths annually. There are two forms of this cancer: 1) low-grade non-invasive tumors or 2) high-grade muscle-invasive tumors. Distinguishing between the two is critical as treatment is drastically different and the 5-year survival for invasive bladder cancer with systemic treatment is less than 5%. To address this unmet need we have designed a novel peripheral blood test based on malignancy-associated sugar polymers (glycans) that is cost-effective, compatible with standard blood collection tubes, and relies only upon conventional clinical reference lab equipment. Glycans are biologically promising as the next generation of cancer markers but, until now, have been analytically intractable in the clinical setting. During our initial phase of working together the MCA team subjected ASUs analytical technology to a blinded study of 30 blood plasma samples from invasive vs. non-invasive UCC cases. Even with common comorbid diseases such as hypertension, obesity and diabetes, the test correctly identified the sample sets and, in the process, identified a promising new candidate marker of invasive UCC with which nearly half of muscle-invasive patients were distinguished from the non-invasive set and, likewise, almost half of non-invasive patients were distinct from the muscle-invasive group. Validation and clinical implementation of these results would provide clear diagnosis for half of UCC patients, with the potential to reduce radiation exposure from unnecessary imaging and morbidity associated with invasive medical procedures. Moreover, as a naturally multiplexed lab test we anticipate being able to identify a unique muscle-invasive UCC biosignature with even greater diagnostic power, given the opportunity to study larger sets of prospectively collected patient samples as outlined below.
|Effective start/end date||10/1/14 → 9/30/17|
- Flinn Foundation: $100,000.00
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