在两项既定筛查计划中，一种基于血液的结直肠癌附加筛查检测的诊断准确性。
Diagnostic Accuracy of an Add-On, Blood-Based Screening Test for Colorectal Cancer in Two Established Screening Programmes.
作者信息
Kortlever Tim L, Ferlizza Enea, Lauriola Mattia, Borrelli Francesco, Porro Alberto, Spaander Manon C W, Bossuyt Patrick M, Ricciardiello Luigi, Dekker Evelien
机构信息
Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.
Department of Medical and Surgical Sciences, Alma Mater Studiorum - University of Bologna, Bologna, Italy.
出版信息
Aliment Pharmacol Ther. 2025 Jun;61(12):1935-1943. doi: 10.1111/apt.70141. Epub 2025 Apr 10.
BACKGROUND
CELTiC is a blood-based test consisting of a panel of four mRNAs (CEACAM6, LGALS4, TSPAN8 and COL1A2) associated with colorectal cancer (CRC). CELTiC has a high sensitivity (90%) for detecting advanced neoplasia (AN) when compared to faecal immunochemical test (FIT)-negative subjects.
AIMS
To evaluate the diagnostic accuracy of CELTiC as an add-on test following a positive FIT in two existing CRC screening programmes.
METHODS
We designed a prospective study in FIT-positive screenees. Analyses were performed in two (partially overlapping) groups: participants with FIT ≥ 47 μg Hb/g faeces (group I) and FIT ≥ 20 μg Hb/g faeces (group II). We estimated CELTIC sensitivity and specificity in detecting AN at a pre-defined and a post hoc threshold (targeted sensitivity: 90%).
RESULTS
We included 809 participants (n = 567 in group I and n = 486 in group II). CELTiC did not reach a sensitivity of 90% at the pre-defined threshold (Group I 41%, group II 27%). At the post hoc thresholds for 90% sensitivity in detecting AN, CELTiC had a specificity of 14% (53/388; 95% CI: 10% to 17%) in group I and 12% (44/354; 95% CI: 9% to 16%) in group II.
CONCLUSIONS
In a FIT-positive population, CELTiC did not reach 90% sensitivity at the pre-defined threshold. At post hoc thresholds corresponding to 90% sensitivity, specificity was low. CELTiC cannot currently be recommended as an add-on test to detect AN in FIT-positive screenees in a CRC screening programme.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT04980443, NCT05205967, NCT04369053.
背景
CELTiC是一种基于血液的检测方法，由一组与结直肠癌（CRC）相关的四种mRNA（癌胚抗原相关细胞黏附分子6、半乳糖凝集素4、四跨膜蛋白8和I型胶原蛋白α2链）组成。与粪便免疫化学检测（FIT）阴性的受试者相比，CELTiC在检测进展期肿瘤（AN）方面具有较高的敏感性（90%）。
目的
在两项现有的CRC筛查项目中，评估CELTiC作为FIT阳性后的附加检测的诊断准确性。
方法
我们对FIT阳性的筛查对象设计了一项前瞻性研究。分析在两个（部分重叠）组中进行：FIT≥47μg血红蛋白/克粪便的参与者（I组）和FIT≥20μg血红蛋白/克粪便的参与者（II组）。我们在预定义阈值和事后阈值（目标敏感性：90%）下估计了CELTIC检测AN的敏感性和特异性。
结果
我们纳入了809名参与者（I组n = 567，II组n = 486）。在预定义阈值下，CELTiC未达到90%的敏感性（I组41%，II组27%）。在检测AN的90%敏感性的事后阈值下，CELTiC在I组中的特异性为14%（53/388；95%CI：10%至17%），在II组中的特异性为12%（44/354；95%CI：9%至16%）。
结论
在FIT阳性人群中，CELTiC在预定义阈值下未达到90%的敏感性。在对应90%敏感性的事后阈值下，特异性较低。目前，在CRC筛查项目中，不推荐将CELTiC作为检测FIT阳性筛查对象中AN的附加检测。
试验注册
ClinicalTrials.gov标识符：NCT04980443、NCT05205967、NCT04369053。
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