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

Recruitingn/aAges 18 Years - anyAllCity of Hope Medical Center
NCT07266363 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Small RNA sequencing of exo- and cf-miRNAs
  • RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay)
  • PCR-based validation (SYNERGY assay)
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Where

1 site
City of Hope Medical Center
Monrovia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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