Early detection of endometrial cancer can increase the 5-year survival rate from <20% to >95%.However, currently there are no non-invasive methods for its detection. We propose the use ofcell-secreted extracellular vesicles (EVs) as the source of new diagnostic biomarkers from uterinelavage - a sample that is much more targeted to endometrial cancer. Within the scope of biomarkerdetection, EVs offer numerous benefits for clinical analysis, including non-invasive collection, asuitable sample source for longitudinal disease monitoring, higher stability and sample volumes,faster processing times and lower cost. However, the analysis of exosomes and other EV has notreally been possible for early endometrial cancer detection. The common procedures for biofluid EVbiomarker analysis are very long and cumbersome due to extremely low target levels and highbackground of free proteins. In order to enable better biomarker discovery and endometrial cancerdiagnosis, a more reliable and efficient approach is needed, capable of enriching potentialcancer-associated proteins with higher purity. In this NIH SBIR Phase I study, we will implement ournovel method for fast and reproducible enrichment of EVs with >95% recovery yield and >99.9%purity for analysis of endometrial cancer from lavage samples. We have already carried out initiallavage EV validation and biomarker discovery experiments, and selected over a dozen ofhigh-quality protein targets that enable effective differentiation of endometrial cancer fromnon-cancer controls. The following aims will be completed in the Phase I of the proposal: Aim #1:Determine the feasibility of the discovered endometrial cancer biomarkers from lavage EVs todifferentiate the disease and refine the panel. Aim #2: Evaluate and implement the novel uterinelavage collection device for fast and effective EV isolation and measurement. By the completion ofthis project, the non-invasive endometrial cancer biomarker discovery platform from lavage EVs willbe developed, and a minimally invasive early endometrial cancer detection assay will be validatedthat can overcome the limitations of current approaches, and thus could have an enormous publichealth impact and market potential.
Public Health Relevance Statement: PROJECT NARRATIVE
Early non-invasive detection of endometrial cancer is the number one priority for
effective treatment. However, no effective wide-spread early diagnostics assay is
currently available. This NIH SBIR Phase I project will support the effort to develop a
new minimally-invasive uterine lavage-based diagnostic assay for early endometrial
cancer detection.
Project Terms: |
