The aim of this study is to enroll 575 eligible stage II colon cancer patients in order to
validate the performance of ColoPrint in estimating 3-year relapse rate.
Secondary objectives include comparing the objective risk assessment results from the
prognostic profile (ColoPrint) to both the risk assessment based on the ASCO criteria, as
well as the Investigator's independent assessment. As this is the first prospective study of
ColoPrint, this study will also address the logistics and quality assurance of using
ColoPrint in clinical practice.
The ColoPrint results will not be reported to the physician and/or patient at the time of
Patient treatment is at the discretion of the physician, adhering to National Comprehensive
Cancer Network (NCCN)-approved regimens or a recognized alternative.
The enrollment period will be 4 years. It is expected that 1800 to 2400 patients will be
enrolled in order to obtain 575 analysable stage II samples from eligible patients.
Approximately 25-35 clinical sites will be involved worldwide.
The statistical analysis will be performed by Agendia and an independent research institute
age ≥ 18 years
adenocarcinoma of the colon
stage II-III, planned to be treated with radical surgery
prior malignancy with the exception of basal cell carcinoma or cervical dysplasia