Identification of early stage diagnosis of colorectal cancer

Background and Rationale: Colorectal cancer (CRC) locally invades and metastasizes to lymph nodes and distal organs with a 5yr survival rate of only 10% (Stage D) while localized CRC (stage A) patients can have ~90% of survival [1]. Early detection of disease at stage A/B (equivalent to the AJCC Stage I/II) is a long-standing unresolved clinical question and is considered the most effective approach to solve the problem.Current screening methods such as gFOBT [2] or FIT [3] have limitations due to patient compliance and lack of sensitivity and specificity to detect a tumour at an early stage, prior to metastasis. Existing CRC biomarkers such as metalloproteinases-1 (TIMP-1) and carcinoembryonic antigen (CEA) are better markers for later stage detection (C/D) or recurrence of cancer. A more sensitive, specific and less invasive diagnostic tool with the utility to predict the onset of the disease at an early stage is imperative.The overarching aim of this study is to develop and implement a new early stage, specific, sensitive blood based diagnostic test.