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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering

EPoS European Polyp Surveillance trial

Alternative title: EPoS

Awarded: NOK 10.2 mill.

This protocol describes an extraordinary group of related randomized trials aiming at addressing one of the most important unsolved challenges in colorectal cancer; the surveillance of patients with premalignant polyps in the large bowel. This project is timely because large scale colorectal cancer screening programmes are currently rolled out in most Western countries. These programmes are diagnosing large numbers of individuals with premalignant polyps (so-called adenomas). This creates both a diagnostic and resource dilemma, because it is currently unknown how these individuals should be surveilled after adenoma removal in order to reduce future cancer risk. The EPoS trials is randomizing individuals in Spain, Norway, the Netherlands, Sweden, Austira, Portugal and Poland to different surveillance colonoscopy intervals to disentangle the most effective and cost-effective surveillance strategy for the population. The primary trial endpoint is incidence of colorectal cancer. EPoS trial I compares 5 to 10-year surveillance for patients with low-risk adenomas; EPoS II compares 3 to 5-year surveillance for patients with high-risk adenomas; and EPoS III addresses the novel issue of serrated polyps (a recently recognized entity) in a single-arm study. This trial compound is unique because it addresses a clinical problem affecting hundreds of thousand individuals each year, its very large size, and because it includes world experts in the field who are determined to joint venture for this largest randomized trial in polyp surveillance trial ever designed. The project is particular important for Norway because 1. Norway has one of the highest incidences of colorectal cancer worldwide, and 2. because Norway has started a national colorectal cancer screening program. The EPoS trial is headed by Norwegian researchers, but entails strong recruitment from abroad to maximise power and thus impact for clinical practice. The EPoS trial has been recruting at 52 centres throughout Europe since 2015. Coinciding with the end of this funings mechanism, the trial will end patient recruitment in the next couple of months and will reah traget for enrollment.Starting in 2020, the trial will enter phase II, surveillance of the enroleld patients. This phase will last until every patient has been examined with their 10 year colonoscoyp, see protocol. So far, several hundreds of patients have already been examined with their 3 year surveillance colonoscopy, and a few have had their 5 year colonoscopy. Because the trial will last much longer than all currently available fundings mechanisms in Europe, and because this funding mechansims ends (which has been crucial for the first phase of the trial), we plan to apply for more funding from this funder and others in the future. The trial is going very weel, and wwe will do our utmost to continue it with the success we have had so far.

Denne startfinansieringen har vært avgjørende for å¨få dette meget krevende men utten tvil enestående prosjektet igang. EpOS er nå i ferd med å vellykket avslutte rekrutteringen av pasienter, og går inn i fase II (surveillance) som skal være i 10 år. EPoS nettverket inkluderer 52 sykehus, med et mylder av aktivitet, ikke bare i hovedstudiene, men med mange undersprosjekter, lokalt, regionalt, nasjonalt, og internasjonalt. EPoS har ført til et betydelig løft av kvaliteten for koloskopier ved de deltagende sykehus og har sterk betydning for utforming av internasjonale retningslinjer for feltet. National Cancer Institute i USA har nylig besluttet å finanisere en amerkikansk EPoS studie (den skal hete FORTE), etter at Institute of Medicine i USA for noen år siden satte problemstillingen som EPoS skal løse som et av de 10 mest presserende problemer å finne ut av i klinisk medisin. FORTE forskerne er i tett dialog med oss i EPoS gruppen for å lage FORTE så lik som mulig som EPoS.

This protocol describes the epos (ancient Greek (?p??) for “story”) of a group of related clinical trials aiming at addressing one of the most important unsolved challenges in the prevention of colorectal cancer (one of our major cancer killers); the surveillance of patients with premalignant polyps in the large bowel. This project is timely because large scale colorectal cancer screening programmes are currently rolled out in most Western countries. These programmes are diagnosing large numbers of individuals with premalignant polyps (adenomas and serrated polyps). This creates both a diagnostic and resource dilemma, because the optimal surveillance strategy for these individuals to reduce future cancer risk is currently unknown. The EPoS trials will randomize or register more than 27,500 individuals in different European countries to different surveillance colonoscopy intervals to disentangle the most effective and cost-effective surveillance strategy for the population. Subjects will be randomized according to their presenting polyp characteristics The EPoS I trial randomizes patients with low-risk adenomas into 5 or 10-year surveillance; EPoS II randomizes patients with high-risk adenomas into 3 or 5-yearly surveillance; EPoS III will include patients with serrated polyps in a one-arm study with surveillance after 5 and 10 years. The primary endpoint for all three trials is incidence of colorectal cancer after 10 years of follow-up. This EPoS trials are the largest in polyp surveillance ever conducted. They address a clinical problem affecting hundreds of thousand individuals in Europe and the US each year, it has a large size, and should thus provide definitive results.

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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering