Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer.
Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer.
复制标题
DOI：
10.1136/gutjnl-2012-304149
复制
发表时间：
2014-02
期刊：
影响因子：
24.5
通讯作者：
PRESEPT Clinical Study Steering Committee, Investigators and Study Team
中科院分区：
文献类型：
--
作者：
Church TR;Wandell M;Lofton-Day C;Mongin SJ;Burger M;Payne SR;Castaños-Vélez E;Blumenstein BA;Rösch T;Osborn N;Snover D;Day RW;Ransohoff DF;PRESEPT Clinical Study Steering Committee, Investigators and Study Team
由于结肠直肠癌（CRC）的筛查方法受到摄取和依从性的限制，因此寻求进一步的选择。血液测试可能会增加这两个，但没有一个在筛查环境中进行过测试。我们前瞻性地评估了循环甲基化SEPT 9 DNA（mSEPT 9）在筛查人群中检测CRC的准确性。计划在32家美国和德国诊所接受筛选结肠镜检查的≥50岁无症状个体在结肠准备前自愿提供血浆样本。使用市售的检测方法，三个独立的设盲实验室在一式两份的真实的PCR中检测所有CRC病例和其他受试者的分层随机样本的血浆DNA。主要结果测量标准化的总体敏感性和特异性估计。7941名男性（45%）和女性（55%），平均年龄60岁，入组。 53例CRC病例和1457例非CRC受试者的结果得出的标准化敏感性为48.2%（95% CI 32.4%至63.6%;粗率50.9%）;对于I-IV期CRC，数值分别为35.0%、63.0%、46.0%和77.4%。特异性为91.5%（95% CI 89.7%-93.1%;粗率91.4%）。晚期腺瘤的敏感性较低（11.2%）。我们使用基于血液的mSEPT 9测试的研究表明，在接受筛查的无症状平均风险个体中可以检测到血液中的CRC信号。然而，用于CRC人群筛查的测试的效用将需要提高检测早期癌症和晚期腺瘤的灵敏度。NCT00855348
As screening methods for colorectal cancer (CRC) are limited by uptake and adherence, further options are sought. A blood test might increase both, but none has yet been tested in a screening setting. We prospectively assessed the accuracy of circulating methylated SEPT9 DNA (mSEPT9) for detecting CRC in a screening population. Asymptomatic individuals ≥50 years old scheduled for screening colonoscopy at 32 US and German clinics voluntarily gave blood plasma samples before colon preparation. Using a commercially available assay, three independent blinded laboratories assayed plasma DNA of all CRC cases and a stratified random sample of other subjects in duplicate real time PCRs. The primary outcomes measures were standardised for overall sensitivity and specificity estimates. 7941 men (45%) and women (55%), mean age 60 years, enrolled. Results from 53 CRC cases and from 1457 subjects without CRC yielded a standardised sensitivity of 48.2% (95% CI 32.4% to 63.6%; crude rate 50.9%); for CRC stages I–IV, values were 35.0%, 63.0%, 46.0% and 77.4%, respectively. Specificity was 91.5% (95% CI 89.7% to 93.1%; crude rate 91.4%). Sensitivity for advanced adenomas was low (11.2%). Our study using the blood based mSEPT9 test showed that CRC signal in blood can be detected in asymptomatic average risk individuals undergoing screening. However, the utility of the test for population screening for CRC will require improved sensitivity for detection of early cancers and advanced adenomas. NCT00855348
登录
查看更多内容
影响因子：
3.5
作者：
Baylin, SB;Esteller, M;Herman, JG
通讯作者：
Herman, JG
影响因子：
9.3
作者：
Lofton-Day, Catherine;Model, Fabian;Sledziewski, Andrew
通讯作者：
Sledziewski, Andrew
影响因子：
24.5
作者：
Church TR;Wandell M;Lofton-Day C;Mongin SJ;Burger M;Payne SR;Castaños-Vélez E;Blumenstein BA;Rösch T;Osborn N;Snover D;Day RW;Ransohoff DF;PRESEPT Clinical Study Steering Committee, Investigators and Study Team
通讯作者：
PRESEPT Clinical Study Steering Committee, Investigators and Study Team
影响因子：
3.7
作者：
Gruetzmann, Robert;Molnar, Bela;Pilarsky, Christian;Habermann, Jens K.;Schlag, Peter M.;Saeger, Hans D.;Miehlke, Stephan;Stolz, Thomas;Model, Fabian;Roblick, Uwe J.;Bruch, Hans-Peter;Koch, Rainer;Liebenberg, Volker;deVos, Theo;Song, Xiaoling;Day, Robert H.;Sledziewski, Andrew Z.;Lofton-Day, Catherine
通讯作者：
Lofton-Day, Catherine
影响因子：
--
作者：
Bossuyt, PM;Reitsma, JB;de Vet, HCE
通讯作者：
de Vet, HCE