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

NCT07266363 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2025-12-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Small RNA sequencing of exo- and cf-miRNAs

Identification of differentially expressed cf-miRNAs

DIAGNOSTIC_TEST

RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay)

RT-qPCR quantification of cf- and exo-miRNAs, and construction of machine learning classifier

DIAGNOSTIC_TEST

PCR-based validation (SYNERGY assay)

PCR-based validation of the SYNERGY miRNA panel

Sponsors & Collaborators

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Ajay Goel, PhD · City of Hope Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2026-06-18
Completion
2026-06-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07266363 on ClinicalTrials.gov