Trial reportAlimentary pharmacology & therapeutics2025
Diagnostic Accuracy of an Add-On, Blood-Based Screening Test for Colorectal Cancer in Two Established Screening Programmes.
Trial report in Alimentary pharmacology & therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prevention of Colorectal Cancer Through Multiomics Blood Testing
CELTiC Trial: an International Multicentre Study Evaluating the CELTiC Panel for the Detection of Advanced Neoplasia in Fecal Immunochemical Test (FIT)-Positive Individuals
REFLECTION: Real World Evidence for Learnings in Early Cancer Detection, a Clinical Practice Learning Program for Galleri®
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
backgroundCELTiC 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.
aimsTo evaluate the diagnostic accuracy of CELTiC as an add-on test following a positive FIT in two existing CRC screening programmes.
methodsWe 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%).
resultsWe 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.
conclusionsIn 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 registrationClinicalTrials.gov identifier: NCT04980443, NCT05205967, NCT04369053.
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Registered trials
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