SYNERGY Study Blood Test Using Cell-Free and Exosomal microRNAs to Detect Esophageal Squamous Cell Carcinoma Early

What this Trial Is About

Esophageal squamous cell carcinoma ESCC is a deadly cancer often diagnosed late, leading to poor outcomes. Current screening methods like upper endoscopy are invasive and limited in detecting early-stage disease. This study aims to develop a non-invasive blood test by combining cell-free microRNAs cf-miRNAs and exosomal microRNAs exo-miRNAs to detect ESCC early when it might be more treatable. The study involves multiple phases including discovery, training, and validation using blood samples collected before surgery. Researchers will analyze small RNA sequencing and perform RT-qPCR to identify and quantify specific miRNAs. These data will be used to build and validate a machine learning model, called the SYNERGY assay, designed to distinguish ESCC patients from non-disease controls using blood biomarkers. Participants will provide preoperative plasma or serum samples that will be analyzed for miRNA patterns. The study will evaluate the sensitivity, specificity, and accuracy of the SYNERGY assay in detecting ESCC. Researchers will monitor and compare the biomarker results across different cohorts, aiming to improve early detection. Participation duration varies based on sample collection and analysis timelines.

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