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

Part of paid clinical trials in Monrovia, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07266363
Status
Recruiting
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Conditions

  • ESCC

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Small RNA sequencing of exo- and cf-miRNAs — DIAGNOSTIC_TEST
    Identification of differentially expressed cf-miRNAs
  • RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay) — DIAGNOSTIC_TEST
    RT-qPCR quantification of cf- and exo-miRNAs, and construction of machine learning classifier
  • PCR-based validation (SYNERGY assay) — DIAGNOSTIC_TEST
    PCR-based validation of the SYNERGY miRNA panel

Study Details

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.

Key Dates

Start date
Jan 15, 2025
Status verified
Dec 2025
Primary completion
Jun 18, 2026
Completion
Jun 18, 2026

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Discovery cohort (ESCC)
    Patients with ESCC
  • Arm: Discovery cohort (NDC)
    Non-Disease Control
  • Arm: Training cohort (ESCC)
    Patients with ESCC
  • Arm: Training cohort (NDC)
    Non-Disease Control
  • Arm: Testing cohort (ESCC)
    Patients with ESCC
  • Arm: Testing cohort (NDC)
    Non-Disease Control

Primary Outcome Measure

Sensitivity [ Time Frame: At study completion, an average of one year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterMonroviaCalifornia91016
Ajay Goel, PhD
[email protected]
626-218-3452

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City of Hope Medical Center· Monrovia, CA

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