An observational study in ESCC, sponsored by City of Hope Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by City of Hope Medical Center · Observational
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.
Esophageal cancer is the 11th most common cancer globally and the 7th leading cause of cancer-related death, with an estimated 511,000 new cases and 445,000 deaths annually. ESCC accounts for the majority of cases worldwide. Despite advances in endoscopy and therapy, outcomes for advanced ESCC remain poor, highlighting the pressing need for sensitive, minimally invasive early detection strategies.
Exosomal miRNAs (exo-miRNAs) are selectively released by tumor cells and remain stable in circulation, enabling reliable detection of tumor-specific signals. Cell-free miRNAs (cf-miRNAs) circulate broadly and can reflect overall tumor burden, metastatic spread, and microenvironmental changes.
Previous ESCC biomarker studies were limited by small validation cohorts and reliance on tissue-based public datasets that do not fully capture circulating biomarker patterns. The SYNERGY study addresses these limitations through comprehensive discovery analysis and multi-cohort blood-based validation.
645 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 275 are open to participants now.
This study's planned enrollment of 600 is above the median of 270 across 93 observational studies indexed under Esophageal Squamous Cell Carcinoma.
Browse Esophageal Squamous Cell Carcinoma studies →City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with histologically confirmed ESCC Healthy volunteers or non-disease controls (NDC)
Exclusion Criteria:
Patients with ESCC
Diagnostic Test: Small RNA sequencing of exo- and cf-miRNAs
Non-Disease Control
Diagnostic Test: Small RNA sequencing of exo- and cf-miRNAs
Patients with ESCC
Diagnostic Test: PCR-based validation (SYNERGY assay)
Non-Disease Control
Diagnostic Test: PCR-based validation (SYNERGY assay)
Patients with ESCC
Diagnostic Test: RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay)
Non-Disease Control
Diagnostic Test: RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay)
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
Sensitivity
Comparison of Pathological Diagnosis and the SYNERGY Assay
Time frame: At study completion, an average of one year
AUC
AUC of integrated cf- + exo-miRNA model
Time frame: At Study completion, an average of one year
Specificity
Description: Comparison of Pathological Diagnosis and the SYNERGY Assay
Time frame: Time Frame: At study completion, , an average of one year
Plan to share: No — De-identified participant data will be made available at the time of publication through a signed data access agreement, pending approval by the investigators for proposed scientific use.
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Esophageal Squamous Cell Carcinoma→
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