Diagnostic Accuracy of an Add-On, Blood-Based Screening Test for Colorectal Cancer in Two Established Screening Programmes

IF 6.6 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Alimentary Pharmacology & Therapeutics Pub Date : 2025-04-10 DOI:10.1111/apt.70141

Tim L. Kortlever, Enea Ferlizza, Mattia Lauriola, Francesco Borrelli, Alberto Porro, Manon C. W. Spaander, Patrick M. Bossuyt, Luigi Ricciardiello, Evelien Dekker

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Abstract

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

Abstract Image

查看原文本刊更多论文

在两个已建立的筛查方案中，一种附加的、基于血液的结直肠癌筛查试验的诊断准确性

CELTiC是一种基于血液的检测，包括与结直肠癌（CRC）相关的四种mrna （CEACAM6、LGALS4、TSPAN8和COL1A2）。与粪便免疫化学试验（FIT）阴性受试者相比，CELTiC在检测晚期肿瘤（AN）方面具有很高的灵敏度（90%）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Alimentary Pharmacology & Therapeutics 医学-胃肠肝病学

CiteScore

15.60

自引率

7.90%

发文量

527

审稿时长

3-6 weeks

期刊介绍： Alimentary Pharmacology & Therapeutics is a global pharmacology journal focused on the impact of drugs on the human gastrointestinal and hepato-biliary systems. It covers a diverse range of topics, often with immediate clinical relevance to its readership.