Radiodiagnostic Section, Department of Clinical Physiopathology, University of Florence, Viale G, Pieraccini 6, 50139 Florence, Italy.
Trials. 2013 Mar 15;14:74. doi: 10.1186/1745-6215-14-74.
Colorectal cancer (CRC) is the most frequent cancer in Europe. Randomized clinical trials demonstrated that screening with fecal occult blood test (FOBT) reduces mortality from CRC. Accordingly, the European Community currently recommends population-based screening with FOBT. Other screening tests, such as computed tomography colonography (CTC) and optical colonoscopy (OC), are highly accurate for examining the entire colon for adenomas and CRC. Acceptability represents a critical determinant of the impact of a screening program. We designed a randomized controlled trial to compare participation rate and diagnostic yield of FOBT, CTC with computer-aided diagnosis, and OC as primary tests for population-based screening.
METHODS/DESIGN: A total of 14,000 subjects aged 55 to 64 years, living in the Florence district and never screened for CRC, will be randomized in three arms: group 1 (5,000 persons) invited to undergo CTC (divided into: subgroup 1A with reduced cathartic preparation and subgroup 1B with standard bowel preparation); group 2 (8,000 persons) invited to undergo a biannual FOBT for three rounds; and group 3 (1,000 persons) invited to undergo OC. Subjects of each group will be invited by mail to undergo the selected test. All subjects with a positive FOBT or CTC test (that is, mass or at least one polyp ≥ 6 mm) will be invited to undergo a second-level OC. Primary objectives of the study are to compare the participation rate to FOBT, CTC and OC; to compare the detection rate for cancer or advanced adenomas of CTC versus three rounds of biannual FOBT; to evaluate referral rate for OC induced by primary CTC versus three rounds of FOBT; and to estimate costs of the three screening strategies. A secondary objective of the study is to create a biological bank of blood and stool specimens from subjects undergoing CTC and OC.
This study will provide information about participation/acceptability, diagnostic yield and costs of screening with CTC in comparison with the recommended test (FOBT) and OC.
ClinicalTrials.gov Identifier: NCT01651624.
结直肠癌（CRC）是欧洲最常见的癌症。随机临床试验表明，粪便潜血试验（FOBT）筛查可降低 CRC 死亡率。因此，目前欧洲共同体建议采用基于人群的 FOBT 筛查。其他筛查试验，如计算机断层结肠成像（CTC）和光学结肠镜检查（OC），对检查整个结肠的腺瘤和 CRC 非常准确。可接受性是筛查计划影响的关键决定因素。我们设计了一项随机对照试验，比较 FOBT、CTC 与计算机辅助诊断和 OC 作为人群筛查的主要检测方法的参与率和诊断率。
方法/设计：共有 14000 名年龄在 55 至 64 岁之间、居住在佛罗伦萨区且从未接受过 CRC 筛查的受试者将被随机分为三组：第 1 组（5000 人）被邀请进行 CTC（分为：准备较少泻药的亚组 1A 和准备标准肠道的亚组 1B）；第 2 组（8000 人）被邀请进行三次双侧 FOBT；第 3 组（1000 人）被邀请进行 OC。每组的受试者将通过邮件邀请进行选择的检测。所有 FOBT 或 CTC 检测阳性的受试者（即肿块或至少一个息肉≥6 毫米）将被邀请进行第二轮 OC。该研究的主要目标是比较 FOBT、CTC 和 OC 的参与率；比较 CTC 与三次双侧 FOBT 对癌症或高级腺瘤的检出率；评估 CTC 对三次 FOBT 的 OC 转诊率；并估计三种筛查策略的成本。该研究的次要目标是从接受 CTC 和 OC 的受试者中建立血液和粪便标本的生物库。
这项研究将提供关于 CTC 筛查与推荐检测方法（FOBT）和 OC 的参与/可接受性、诊断率和成本的信息。
ClinicalTrials.gov 标识符：NCT01651624。
