Study Design



   

The Timing To Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy For Rectal Cancer: A Multicenter Randomized Controlled Trial – Biomarkers SubStudy is an observational study on the evaluation of the circulating miRNA in serum.
This study is intended as a prospective collection of serum sample, that will be stored and further analyzed, in the institutional biobank.

   

All included patients in the TiMiSNAR Trial are supposed to undergo blood collection at the time of diagnosis, after neoadjuvant treatment, after 1 month from surgery.

   



   

PRIMARY OBJECTIVE

 

To evaluate the association of variation between preneoadjuvant and postneoadjuvant expression levels of miRNA with pCR

   


   

SECONDARY OBJECTIVES

 

  • To evaluate the role of liquid biopsies in the monitoring of treatment
  • To correlate changes in expression levels of miRNA following complete surgical resection with disease-free survival
  • To evaluate the relation between changes in miRNA during surveillance and tumor relapse