SYNERGY Study: Early Detection Through Integrated Evaluation of Cell-Free and Exosomal microRNAs for Biomarker-Guided Screening of Esophageal Squamous Cell Carcinoma

What this Trial Is About

Esophageal squamous cell carcinoma (ESCC) is a deadly form of cancer often diagnosed late, leading to poor outcomes. Current screening methods like upper endoscopy are invasive and depend on the operator, limiting early detection. This research aims to develop a non-invasive blood test that combines cell-free and exosomal microRNAs to detect ESCC at an early, potentially curable stage. The SYNERGY study includes discovery, training, and validation phases to build a precise diagnostic model with high sensitivity and specificity. Participants in this multicenter study provide preoperative plasma or serum samples for analysis. The study uses several advanced laboratory techniques including small RNA sequencing, RT-qPCR quantification, and PCR-based validation to identify and confirm microRNA patterns linked to ESCC. Control groups without malignant disease are also included to improve the accuracy of the biomarker model. During the study, participants undergo blood sample collection for microRNA analysis without receiving treatment interventions. Researchers will assess the test's sensitivity and specificity approximately one year after study completion. The study also measures the area under the curve (AUC) to evaluate diagnostic performance. Participants may be healthy volunteers or patients with ESCC, and their samples contribute to building a reliable, minimally invasive screening test.

Integrated Cf-miRNA and Exosomal miRNA Signature for Early Detection of Esophageal Squamous Cell Carcinoma