At a glance
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SYNERGY Study: Early Detection Through Integrated Evaluation of Cell-Free and Exosomal microRNAs for Biomarker-Guided Screening of Esophageal Squamous Cell Carcinoma
In Brief
An observational study evaluating Small RNA sequencing of exo- and cf-miRNAs, RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay), and 1 other intervention for ESCC. Currently recruiting, targeting 600 participants across 1 site.
Detailed Summary
Esophageal squamous cell carcinoma (ESCC) remains a highly lethal cancer worldwide, largely due to late diagnosis. Current screening methods such as upper endoscopy are invasive, operator-dependent, and limited in their ability to detect early-stage lesions. To address this clinical need, the SYNERGY study seeks to develop a non-invasive, blood-based biomarker assay that integrates cell-free microRNAs (cf-miRNAs) and exosomal microRNAs (exo-miRNAs) to detect ESCC at an early and potentially curable stage. This multicenter translational study includes discovery, training, and validation phases using preoperative plasma or serum samples. By combining the tumor specificity of exosomal miRNAs with the systemic sensitivity of cf-miRNAs, SYNERGY aims to construct a robust diagnostic model with high sensitivity and specificity for early ESCC detection.
Study Details
Timeline
Interventions
Identification of differentially expressed cf-miRNAs
RT-qPCR quantification of cf- and exo-miRNAs, and construction of machine learning classifier
PCR-based validation of the SYNERGY miRNA panel