Integrated Cf-miRNA and Exosomal miRNA Signature for Early Detection of Esophageal Squamous Cell Carcinoma
SYNERGY Study: Early Detection Through Integrated Evaluation of Cell-Free and Exosomal microRNAs for Biomarker-Guided Screening of Esophageal Squamous Cell Carcinoma
City of Hope Medical Center
600 participants
Jan 15, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Adults age 18 to 90 years
- Histologically confirmed esophageal squamous cell carcinoma
- No prior systemic therapy before sample collection
- For control groups: absence of malignant disease
Exclusion Criteria4
- Lack of informed consent
- Inadequate sample volume or RNA quality
- Prior cancer within 5 years (except localized cancers)
- Active systemic inflammation that may alter circulating RNA profiles
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
Locations(1)
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NCT07266363