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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
Who can join
Ages 18 and older · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
About the study
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.
What is being tested
- Small RNA sequencing of exo- and cf-miRNAs (diagnostic test)
- RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay) (diagnostic test)
- PCR-based validation (SYNERGY assay) (diagnostic test)
Sponsor: City of Hope Medical Center · Participants: 600 · Started: Jan 15, 2025
Contact the study team
- Ajay Goel, PhD · Phone: 626-218-3452
Official record on ClinicalTrials.gov — NCT07266363
Locations in the U.S.
| California | City of Hope Medical Center, Monrovia |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.