EDRN Pre-Validation Study/Rectal Nanocytology for Colonic Risk Stratification: Transitioning into the Clinic Setting

This is a proposal to validate altered rectal nanocytology as a biomarker for colon carcinogenesis. This biomarker has been developed in the EDRN’s Boston University-Northwestern University Biomarker Development Laboratory led by Drs. Roy and Backman. Our current BDL project has affirmed the promise of rectal nanocytology as biomarker for colonic field carcinogenesis and hence risk stratification from samples immediately prior to colonoscopy. In order to perform a definitive blinded multicenter validation of this project, we first need to demonstrate feasibility. This includes three issues 1. Demonstrate that readings can be taken in unprepped setting and this correlates with our previous prepped data. 2. Establish that the final PWS instrument with automated 3. Show that this approach is robust enough in multi-center studies. that the ability of rectal nanocytology to sense advance adenomas can also be sensitive in the unprepped setting (similar to the vision for clinical practice). This will be done using the final instrumentation and will also be multicentered. This will be a multicenter blinded validation study using 3 clinical centers (Boston Medical Center, Northwestern Memorial HealthCare and University and Chicago). The patient recruitment will be coordinated by the clinical core run by Dr. Roy. The clinical core will be responsible for training investigators, aiding in IRB processing and quality control. The technology core run by Dr. Backman will be responsible for all facets of the biomarker analysis, including manufacturing the instrumentation, calibration, quality control, making slides from brushings and data analysis. He and his team will be blinded to clinical findings. The merging of clinical and PWS data will be performed at the DMCC.