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Review
. 2024;42(1):12-24.
doi: 10.1159/000533395. Epub 2023 Sep 27.

Considerations for Colorectal Neoplasia Detection in Inflammatory Bowel Disease Clinical Trials

Mira M Yang  1 , Keith Usiskin  1 , Harris A Ahmad  1 , Shabana Ather  1 , Antoine Sreih  1 , James B Canavan  1 , Francis A Farraye  2 , Christopher Ma  3   4
Affiliations
Review

Considerations for Colorectal Neoplasia Detection in Inflammatory Bowel Disease Clinical Trials

Mira M Yang et al. Dig Dis. 2024.

Abstract

Background: High-quality colonoscopic surveillance can lead to earlier and increased detection of colorectal neoplasia in patients with inflammatory bowel disease (IBD). In IBD clinical trials, endoscopy is used to assess mucosal disease activity before and after treatment but also provides an opportunity to surveil for colorectal neoplasia during follow-up.

Summary: Best practices for colorectal cancer identification in IBD clinical trials require engagement and collaboration between the clinical trial sponsor, site endoscopist and/or principal investigator, and central read team. Each team member has unique responsibilities for maximizing dysplasia detection in IBD trials.

Key messages: Sponsors should work in accordance with scientific guidelines to standardize imaging procedures, design the protocol to ensure the trial population is safeguarded, and oversee trial conduct. The site endoscopist should remain updated on best practices to tailor sponsor protocol-required procedures to patient needs, examine the mucosa for disease activity and potential dysplasia during all procedures, and provide optimal procedure videos for central read analysis. Central readers may detect dysplasia or colorectal cancer and a framework to report these findings to trial sponsors is essential. Synergistic relationships between all team members in IBD clinical trials provide an important opportunity for extended endoscopic evaluation and colorectal neoplasia identification.

Keywords: Clinical trial; Colorectal cancer; Colorectal neoplasms; Endoscopy; Inflammatory bowel disease.

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Conflict of interest statement

M.M.Y. was an employee of Bristol Myers Squibb at the time of manuscript initiation. H.A.A., S.A., and A.S. are employees and shareholders of Bristol Myers Squibb. J.B.C. was an employee of Bristol Myers Squibb at the time of manuscript submission. K.U. was an employee of Bristol Myers Squibb at the time of manuscript initiation and currently serves as a paid consultant. F.A.F. has received consulting fees from Arena, BMS, Braintree Labs, GI Reviewers, GSK, IBD Educational Group, Innovation Pharmaceuticals, Iterative Scopes, Janssen, Pfizer, and Sebela. He serves on a data safety monitoring board for Bacainn Therapeutics, Lilly, and Theravance. C.M. has received consulting fees from AbbVie, Amgen, AVIR Pharma Inc, Ferring, Fresenius Kabi, Janssen, McKesson, Mylan, Takeda, Pfizer, Roche, and Alimentiv (formerly Robarts Clinical Trials Inc.); speaker’s fees from AbbVie, AVIR Pharma Inc, Janssen, Takeda, and Pfizer; and research support from Pfizer.

Figures

Fig. 1.
Fig. 1.
Endoscopic mucosal resections of a 1.2-cm visible nonpolypoid superficial elevated dysplasia in individual with ulcerative colitis (a); the resected lesion is lifted after injection with indigo-carmine (b). Reprinted from Hong (2017) [14].
Fig. 2.
Fig. 2.
Flow diagram depicting the feedback loop between the sponsor, site endoscopists, and the central read time when addressing incidental findings (IF) in IBD clinical trials [43]. *The principal investigator and the site endoscopist may or may not be the same individual. **Potential IF disclosure after thorough assessment of net benefit. IBD, inflammatory bowel disease; IF, incidental findings.
See this image and copyright information in PMC

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