Delivering New Promise for Colon Cancer Patients

ColoPrint^® and the PARSC Clinical Trial for Colon Cancer Recurrence Risk

The PARSC (Prospective Analysis of Risk Stratification by ColoPrint) Trial is a multi-center, multi-national, prospective study for the assessment of recurrence risk in Stage II and III Colon Cancer patients.  This study will address the feasibility and quality assurance of the ColoPrint gene expression profile in clinical practice.  ColoPrint risk assessment results will be compared to the risk assessment resulting from various clinical parameters following local/ASCO criteria and independent investigator criteria.

Objectives

1. Organization and controlled implementation of ColoPrint for prognosis and prediction.
2. The prospective comparison of the ColoPrint recurrence risk signature versus clinical parameters based on local protocol and ASCO high-risk recommendations, which account for the presence of at least one of the following: T4, perforation/ obstruction, G3, and inadequate node sampling (less than 12 nodes).
3. Validation of the ColoPrint gene expression profile as a powerful and clinically useful prognostic tool for recurrence risk assessment in comparison to traditional clinical risk factors for accurate prediction of the 3 year relapse rate.
4. To assess the proportion of ‘good prognosis profile’ and ‘poor prognosis profile’ in stage II and III colon cancer patients in the two ColoPrint risk categories in different ethnic populations and in different countries.
5. Measure how ColoPrint results alter clinical treatment decisions. 
   
   

Inclusion criteria

• Age ≥ 18 years
• Adenocarcinoma of the colon
• Stage I, II, III, planned to be treated with radical surgery 
  
  

Exclusion Criteria

• Prior malignancy with the exception of basal cell carcinoma or cervical dysplasia
• Any neo-adjuvant therapy
• Synchronous tumors

For additional information on Agendia’s PARSC clinical trial please visit ClinicalTrials.Gov:  Colon Cancer Clinical Trial