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Integrated Cf-miRNA and Exosomal miRNA Signature for Early Detection of Esophageal Squamous Cell Carcinoma
Sponsor: City of Hope Medical Center
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.
Official title: SYNERGY Study: Early Detection Through Integrated Evaluation of Cell-Free and Exosomal microRNAs for Biomarker-Guided Screening of Esophageal Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
600
Start Date
2025-01-15
Completion Date
2026-06-18
Last Updated
2025-12-05
Healthy Volunteers
Yes
Conditions
Interventions
Small RNA sequencing of exo- and cf-miRNAs
Identification of differentially expressed cf-miRNAs
RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay)
RT-qPCR quantification of cf- and exo-miRNAs, and construction of machine learning classifier
PCR-based validation (SYNERGY assay)
PCR-based validation of the SYNERGY miRNA panel
Locations (1)
City of Hope Medical Center
Monrovia, California, United States