At a glance
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Machine Learning-Based Exosomal microRNA Signature for Preoperative Staging and Chemotherapy Eligibility in Colon Cancer
In Brief
An observational study evaluating Diagnostic Test: EXPOSE assay(Small RNA-seq of exosomal miRNAs) and Diagnostic Test: EXPOSE RT-qPCR panel for Colon Cancer. Currently recruiting, targeting 400 participants across 1 site.
Detailed Summary
Recent studies have highlighted the potential benefits of neoadjuvant chemotherapy (NAC) in colon cancer; however, its indication is generally limited to cases corresponding to pathological stage IIB or higher. Accurately identifying such high-risk cases before surgery remains challenging using conventional clinical diagnostics alone. Therefore, we hypothesized that integrating molecular biomarkers with preoperative clinical assessment could provide a more precise and sensitive evaluation of tumor aggressiveness. In this context, we focused on exosomal microRNAs, which are actively secreted from tumor cells and remain stable in circulation, and aimed to develop a machine learning-based biomarker panel. To achieve this, we initiated a multicenter study utilizing preoperative plasma samples to establish a reliable biomarker model for risk stratification and treatment decision-making in colon cancer.
Study Details
Timeline
Interventions
Candidates identified from small RNA sequencing
Quantification of exosomal microRNAs (RT-qPCR)