im3D SpA, Turin, Italy.
Trials. 2014 Mar 28;15:97. doi: 10.1186/1745-6215-15-97.
Colorectal cancer (CRC) is the second most prevalent type of cancer in Europe. A single flexible sigmoidoscopy (FS) screening at around the age of 60 years prevents about one-third of CRC cases. However, FS screens only the distal colon, and thus mortality from proximal CRC is unaffected. Computed tomography colonography (CTC) is a highly accurate examination that allows assessment of the entire colon. However, the benefit of CTC testing as a CRC screening test is uncertain. We designed a randomized trial to compare participation rate, detection rates, and costs between CTC (with computer-aided detection) and FS as primary tests for population-based screening.
METHODS/DESIGN: An invitation letter to participate in a randomized screening trial comparing CTC versus FS will be mailed to a sample of 20,000 people aged 58 or 60 years, living in the Piedmont region and the Verona district of Italy. Individuals with a history of CRC, adenomas, inflammatory bowel disease, or recent colonoscopy, or with two first-degree relatives with CRC will be excluded from the study by their general practitioners. Individuals responding positively to the invitation letter will be then randomized to the intervention group (CTC) or control group (FS), and scheduled for the screening procedure. The primary outcome parameter of this part of the trial is the difference in advanced neoplasia detection between the two screening tests. Secondary outcomes are cost-effectiveness analysis, referral rates for colonoscopy induced by CTC versus FS, and the expected and perceived burden of the procedures. To compare participation rates for CTC versus FS, 2,000 additional eligible subjects will be randomly assigned to receive an invitation for screening with CTC or FS. In the CTC arm, non-responders will be offered fecal occult blood test (FOBT) as alternative screening test, while in the FS arm, non-responders will receive an invitation letter to undergo screening with either FOBT or CTC. Data on reasons for participation and non-participation will also be collected.
This study will provide reliable information concerning benefits and risks of the adoption of CTC as a mass screening intervention in comparison with FS. The trial will also evaluate the role of computer-aided detection in a screening setting.
ClinicalTrials.gov Identifier: NCT01739608.
结直肠癌（CRC）是欧洲第二大常见癌症类型。在大约 60 岁时进行单次乙状结肠镜检查（FS）筛查可预防约三分之一的 CRC 病例。然而，FS 仅筛查远端结肠，因此近端 CRC 的死亡率不受影响。计算机断层结肠成像（CTC）是一种高度准确的检查，可以评估整个结肠。然而，CTC 检测作为 CRC 筛查试验的益处尚不确定。我们设计了一项随机试验，以比较 CTC（结合计算机辅助检测）和 FS 作为人群筛查的主要检测方法的参与率、检出率和成本。
方法/设计：将参加一项比较 CTC 与 FS 作为人群筛查的随机试验的邀请信邮寄给居住在意大利皮埃蒙特地区和维罗纳区的 20,000 名 58 或 60 岁的人。有 CRC、腺瘤、炎症性肠病或最近接受过结肠镜检查病史，或有两名一级亲属患有 CRC 的个体将被他们的全科医生排除在研究之外。对邀请信作出积极回应的个体将被随机分配到干预组（CTC）或对照组（FS），并安排进行筛查程序。该试验这一部分的主要结局参数是两种筛查试验在检出高级肿瘤方面的差异。次要结局是成本效益分析、CTC 与 FS 诱导的结肠镜检查转诊率，以及程序的预期和感知负担。为了比较 CTC 与 FS 的参与率，将另外随机分配 2,000 名符合条件的受试者接受 CTC 或 FS 筛查的邀请。在 CTC 组中，未应答者将接受粪便潜血试验（FOBT）作为替代筛查试验，而在 FS 组中，未应答者将收到接受 FOBT 或 CTC 筛查的邀请信。还将收集有关参与和不参与的原因的数据。
本研究将提供有关采用 CTC 作为与 FS 相比的大规模筛查干预措施的益处和风险的可靠信息。该试验还将评估计算机辅助检测在筛查环境中的作用。
ClinicalTrials.gov 标识符：NCT01739608。
