Predicting Response to Standardized Pediatric Colitis Therapy (PROTECT)
Principal Investigator: Professor Subra Kugathasan
Approved Research ID: 15272
Approval date: November 3rd 2015
The predicting response to standardized pediatric colitis therapy (PROTECT Study), funded by the National Institutes of Health (NIH) is a multicenter study between over 30 academic centers and hospitals in the US and Canada. The overall aim of this study is to standardize therapy for newly diagnosed ulcerative colitis patients using specific clinical, genetic, and immune parameters that will predict subsequently severe disease as reflected by need for escalation of medical therapy. It is the largest to date inception cohort of pediatric ulcerative colitis patients. No outpatient study to date have biological and molecular data been prospectively collected in parallel with thorough clinical data. The DNA collected in PROTECT will be available for assessment of UC susceptibility genes, currently and yet to be identified, and equally importantly, for assessment of polymorphisms in genes associated with corticosteroid response. This will allow study of factors important to pathogenesis, and will form the basis of ongoing modifications of therapeutic regimens based on clinical, genetic and serologic variables. It will represent the first large-scale attempt to advance knowledge and improve outcomes in this rare and often devastating disease. We would like to receive the full cohort for our study. We will then choose the controls and run the analysis on our end.