IBD Neoplasia Surveillance Pilot RCT

Titre officiel

A Randomized, Parallel-Group, Non-Inferiority Trial Comparing Random AND Targeted Biopsies to Targeted Biopsies Alone for Neoplasia Screening in Adult Persons With Colonic Inflammatory Bowel Diseases: A Pilot Study

Sommaire:

Afin de déterminer si les biopsies aléatoires peuvent être retirées de la période de sélection pour les personnes atteintes d’une maladie inflammatoire de l’intestin (MII) à risque modéré sans conséquence sur la sécurité, les investigateurs proposent un essai pilote à répartition aléatoire et contrôlé visant à comparer des biopsies ciblées utilisées seules et en combinaison avec des biopsies aléatoires, selon le taux de capture des lésions précancéreuses, les effets secondaires et le risque de cancer colorectal (CCR). L’étude pilote tentera de capturer 20 % de la population totale de l’étude afin d’évaluer la faisabilité de recruter le nombre nécessaire de participants dans le délai établi, tout en maintenant la qualité (élevée) de la collecte de données.

Description de l'essai

Primary Outcome:

• Overall Number of Participants Enrolled
• Rate of Protocol Adherence
• Rate of overall neoplasia detection
• Adverse Events occurrence

Secondary Outcome:

• Rate of Study Variables
• Rate of Missed 2-Week Post-Procedural Assessment for Complications

Inflammatory Bowel Disease (IBD), including crohn's disease and ulcerative colitis, is a group of diseases characterized by acute and chronic inflammation of the intestinal tract. Persons with IBD are at an increased risk of developing colorectal cancer (CRC) and require frequent CRC screening with colonoscopy. Current IBD screening guidelines recommend the taking of biopsies of any lesions suspected to be pre-cancerous (targeted biopsies), as well as the taking of 30 to 40 random biopsies throughout the colon. The recommendations for random biopsies are based on historical practice and the theory that they would capture "invisible lesions", but are not supported by strong scientific evidence. In fact, recent evidence has shown that random biopsies capture a very small number of pre-cancerous lesions and that they capture such lesions only in persons with additional risk factors for CRC. In addition, new colonoscopy practices and technology have made 80-90% of pre-cancerous lesions visible. Random biopsies also carry potential risks for patients, including lower gastrointestinal bleeding and bowel perforation, and substantially increase procedural costs and time. Hence, there is a strong impetus to conduct a well-powered non-inferiority Randomized Controlled Trial (RCT) on this topic in a Canadian setting. With the support of a pan-Canadian IBD clinical trials alliance (the Canadian IBD Research Consortium (CIRC)), and the high prevalence of IBD in Canada, Canadian investigators are well-positioned to undertake such a trial. Before embarking on a large multi-centre trial, a one-year pilot feasibility trial will be conducted to ensure that patients can be enrolled efficiently with excellent protocol compliance. A feasibility trial will also provide a crude estimate of the neoplasia detection rate (primary outcome) among persons with colon IBD (cIBD) in Canada, which will allow refinement of the sample size, recruitment period and budget for a definitive trial. To-date, no well-powered or North American RCTs have evaluated random biopsies as an intervention to guide our estimates for a definitive trial.

Voir cet essai sur ClinicalTrials.gov