The NordICC Study: rationale and design of a randomized trial on colonoscopy screening for colorectal cancer.
The NordICC Study: rationale and design of a randomized trial on colonoscopy screening for colorectal cancer.
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DOI：
10.1055/s-0032-1306895
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发表时间：
2012-07
期刊：
影响因子：
9.3
通讯作者：
Hoff G
中科院分区：
文献类型：
--
作者：
Kaminski MF;Bretthauer M;Zauber AG;Kuipers EJ;Adami HO;van Ballegooijen M;Regula J;van Leerdam M;Stefansson T;Påhlman L;Dekker E;Hernán MA;Garborg K;Hoff G
虽然结肠镜筛查在几个欧洲国家和美国广泛使用，但没有随机试验来量化其益处。北欧结直肠癌倡议（NordICC）是一项多国随机对照试验，旨在研究结肠镜筛查对结直肠癌发病率和死亡率的影响。本文描述了NordICC试验的原理和设计。从参与国家的人群登记中抽取55 - 64岁的男性和女性，并随机分配至仅一次结肠镜筛查并切除所有检测到的病变或不进行筛查（试验地区的标准治疗）。所有个人在纳入后使用专门的国家登记处随访15年。试验的主要终点是15年随访期间累积的CRC特异性死亡和CRC发生率。我们假设结肠镜检查干预降低50% CRC死亡率的有效性，并预测50%的依从性，在那些被邀请进行筛查的患者中，死亡率降低25%。对于90%的把握度和双侧α水平0.05，使用2：1的随机化，45，600例受试者将随机分配至对照组，22，800例受试者将随机分配至结肠镜检查组。结肠镜检查对CRC发病率和死亡率影响的中期分析将在10年随访时进行。NordICC试验的目的是量化基于人群的结肠镜筛查的有效性。这将允许在一般人群中制定以证据为基础的CRC筛查指南。
While colonoscopy screening is widely used in several European countries and the United States, no randomised trials exist to quantify its benefits. The Nordic-European Initiative on Colorectal Cancer (NordICC) is a multinational, randomized controlled trial aiming at investigating the effect of colonoscopy screening on CRC incidence and mortality. This paper describes the rationale and design of the NordICC trial. Men and women age 55 to 64 years are drawn from the population registries in the participating countries and randomly assigned to either once-only colonoscopy screening with removal of all detected lesions, or no screening (standard of care in the trial regions). All individuals are followed for 15 years after inclusion using dedicated national registries. The primary endpoints of the trial are cumulative CRC-specific death and CRC incidence during 15 years of follow up. We hypothesize a 50% CRC mortality-reducing efficacy of the colonoscopy intervention and predict 50% compliance, yielding a 25% mortality reduction among those invited to screening. For 90% power and a two-sided alpha level of 0.05, using a 2:1 randomisation, 45,600 individuals will be randomised to control, and 22,800 individuals to the colonoscopy group. Interim analyses of the effect of colonoscopy on CRC incidence and mortality will be performed at 10 years follow-up. The aim of the NordICC trial is to quantify the effectiveness of population-based colonoscopy screening. This will allow development of evidence-based guidelines for CRC screening in the general population.