[URBI Study] A Randomized Trial of the Utility of Random Biopsies in Patients with Inflammatory Bowel Disease

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Funding: NIDDK
Investigator: Lewis, J

The URBI study is a multicenter parallel group clinical trial. The primary objective is to determine if high-definition white light colonoscopy (HDWLC) using a limited biopsy strategy is non-inferior to HDWLC with a random 4x10cm biopsy strategy to detect dysplasia or sessile serrated adenoma (SSA) in patients with inflammatory bowel disease (IBD). Additional objectives of the study are to determine if HDWLC with a limited biopsy strategy is superior to HDWLC with a random 4x10cm biopsy strategy to detect one or more dysplastic or SSA lesion in patients with IBD, determine whether the number of targeted biopsies differs based on the number of random biopsies obtained and to define the molecular characteristics of the progression of colitis-associated dysplasia.

The URBI study started in July 2024. The CRCU supports the study with project management and data management services.

Clinical trials.gov NCT06560021