About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Small RNA sequencing of exo- and cf-miRNAs
- RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay)
- PCR-based validation (SYNERGY assay)
Treatment groups
6
Treatment groupsSee each treatment group below.