Observational studyJCO precision oncology2026
Cell-Free DNA Analysis With Clinicopathologic Factors for Early Detection and Refining Lymph Node Metastasis Risk in T1 Colorectal Cancer: Results From the COSMOS-CRC Study.
Observational study in JCO precision oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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21 authors.
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Abstract
purposeThe Shield test is a blood-based assay that uses multimodal analysis of cell-free DNA (cfDNA) to enable noninvasive colorectal cancer (CRC) detection. The aim of this study was to assess the diagnostic performance of the cfDNA test for CRC and advanced precancerous lesions (APLs) and evaluate its potential clinical utility, particularly in early-stage disease.
methodsIn this prospective, multicenter study, 451 patients with histologically confirmed CRC or APLs were enrolled across eight institutions. Blood samples collected before treatment were analyzed using the cfDNA test (Shield, Guardant Health, United States). We assessed the sensitivity of the test for different CRC stages and APLs. In addition, we examined the correlation between test positivity and clinicopathologic factors in stage I and T1 CRC.
resultsThe test showed 87.9% sensitivity for CRC overall, with stage-specific sensitivities of 71.2% for stage I and 97.4% for stages II-IV. Sensitivity for APLs was 37.0%. In stage I CRC, test positivity was significantly associated with tumor depth (T2: 88.6%
conclusionThis cfDNA blood-based test shows a robust diagnostic performance in CRC detection. It may improve risk stratification and support more tailored clinical decision making, particularly in the management of T1 CRC.
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