ArticleJCO precision oncology2026
EXONERATE-TRaCE: A Liquid Biopsy for Tracking Response to Anti-Epidermal Growth Factor Receptor-Based Therapy in Metastatic Colorectal Cancer.
Article in JCO precision oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07700992 (An Exosome-based and Machine-learning-powered Liquid Biopsy for Pancreatic Cancer Early-detection and Disease Monitoring), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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An Exosome-based and Machine-learning-powered Liquid Biopsy for Pancreatic Cancer Early-detection and Disease Monitoring
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8 authors.
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Abstract
purposeThe EXOsome and cell-free microRNAs (miRNAs) of anti-epidermal growth factor receptor (EGFR) Resistance (EXONERATE) study previously developed and validated a liquid biopsy to predict the efficacy of first-line anti-EGFR therapy in metastatic colorectal cancer (mCRC) from treatment-naïve blood samples. This study evaluates the performance of the EXONERATE assay during therapy as a tool for monitoring the emergence of anti-EGFR resistance before it becomes clinically or radiologically apparent.
methodsRetrospective, single-center, longitudinal, REMARK-compliant biomarker study assessing the ability of a liquid biopsy to predict response to anti-EGFR monoclonal antibodies and to track resistance development longitudinally. Fifty-two patients with RAS wild-type mCRC provided 142 plasma samples during administration of first-line anti-EGFR-based therapy.
resultsBaseline EXONERATE scores predicted response with 83.3% specificity and 77.3% sensitivity (area under the receiver operating characteristic curve [AUROC] = 89.4%). Longitudinal analyses demonstrated that biomarker changes closely tracked tumor burden and anticipated clinical and radiological progression, outperforming conventional tumor markers CEA and CA19-9. Stepwise optimization produced a reduced panel (four cell-free-miRNAs and five exo-miRNAs), EXONERATE-Tracking Response and Clinical Evolution (TRaCE), which retained high predictive accuracy (AUROC = 94.4%) while enabling more practical, repeated monitoring. EXONERATE-TRaCE values increased during the 3 months preceding the first clinical or radiological evidence of progression and reliably detected early progression in both left- and right-sided tumors, including patients with lung metastases, and identified resistance up to 3 months before radiological confirmation.
conclusionEXONERATE-TRaCE extends the predictive utility of the original EXONERATE assay into a practical monitoring tool. This liquid biopsy detects emerging anti-EGFR resistance earlier than conventional markers and may inform treatment monitoring and support timely clinical decision making in mCRC.
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