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RECRUITING
NCT07266363

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

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

Small RNA sequencing of exo- and cf-miRNAs

Identification of differentially expressed cf-miRNAs

DIAGNOSTIC_TEST

RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay)

RT-qPCR quantification of cf- and exo-miRNAs, and construction of machine learning classifier

DIAGNOSTIC_TEST

PCR-based validation (SYNERGY assay)

PCR-based validation of the SYNERGY miRNA panel

Locations (1)

City of Hope Medical Center

Monrovia, California, United States