RecruitingNCT07266363

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


Sponsor

City of Hope Medical Center

Enrollment

600 participants

Start Date

Jan 15, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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

Interventions

DIAGNOSTIC_TESTSmall RNA sequencing of exo- and cf-miRNAs

Identification of differentially expressed cf-miRNAs

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

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

DIAGNOSTIC_TESTPCR-based validation (SYNERGY assay)

PCR-based validation of the SYNERGY miRNA panel


Locations(1)

City of Hope Medical Center

Monrovia, California, United States

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NCT07266363


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