Adenoma burden measurement in FAP: Necessary to chemo prevention trials and clinical management alike

Patrick Lynch1, Luigi Luigi Ricciardiello2, Dora Colussi2, Juan Posadas1

1MDAnderson, Houston, USA. 2Universty of Bologna, Bologna, Italy



Purpose: To introduce a process that has been developed for the capture and management of video images used in clinical chemoprevention trials

Methods:  Multicenter European randomised prospective trial of eicosapentaenoic acid (EPA) in FAP with colectomy and evaluable rectal adenoma burden. Incorporating elements from previous initiatives and trials, we have developed, under the sponsorship of SLA Pharma, a process that includes: a) capture of video footage of baseline and follow-up endoscopy; b) transmission to central repository; c) central editing of videos; d) posting of edited videos for rapid review for quality control (eligibility and evaluability); e) quantitation of adenoma burden by defined pool of scorers.

Results: Preliminary data from early enrolment cases indicate the work-flow to be successful in flagging cases warranting special attention, including marked variation in polyp counts by scorers and cases failing to meet eligibility criteria endoscopically.  Polyp scoring is otherwise proceeding smoothly by committee participants.

Features of this process are enabling convenient data management of primary endpoint data and quality control over endpoint measurement at each step.  We anticipate variations upon this approach to be explored in similar trials, with the goal of arriving at a standardized approach to endpoint scoring.  Improvements in endoscopic imaging, including potentially artificial intelligence, will continue to evolve, but will still require elements of the work-flow described here