Primary Objective • To validate the performance of ColoPrint in estimating the 3-year relapse rate in patients with stage II colorectal cancer.
Secondary Objectives
• To assess the feasibility of using the ColoPrint test in the clinical setting.
* To compare the risk assessment in stage II patients using the ColoPrint profile vs a clinical risk assessment based on 1) Investigator's assessment of risk and 2) ASCO high-risk recommendations (T4 lesions, perforation / obstruction, inadequate node sampling (less than 12 nodes) or poorly differentiated histology).
* To establish the proportion of low-risk and high-risk ColoPrint profiles in stage II colorectal cancer patients in various countries.
* To investigate therapy as a potential confounding factor for ColoPrint results.
* To assess the performance of ColoPrint in estimating the 3-year relapse rate in patients with stage III colorectal cancer.
* To compare the performance of ColoPrint vs the clinical risk assessment in estimating the 5-year relapse rate.
* Assess the impact of ColoPrint on adjuvant chemotherapy treatment decisions in stage 2 colorectal cancer patients
* Compare the ColoPrint results from fresh RNARetain colorectal tumor specimens to the matched formalin-fixed paraffin-embedded tissue (FFPE) colon tumor specimens for concordance.
