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

City of Hope Medical Center · NCT07266363

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
600
US sites recruiting
1
Study start
January 15, 2025
Record last updated
July 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Small RNA sequencing of exo- and cf-miRNAs; RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay); PCR-based validation (SYNERGY assay)

Conditions: ESCC

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • City of Hope Medical Center

    Monrovia, CA 91016

    Site contact: Ajay Goel, PhD · 626-218-3452 · ajgoel@coh.org

Study contacts (from the official record)

  • Ajay Goel, PhD · 626-218-3452 · ajgoel@coh.org
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Integrated Cf-miRNA and Exosomal miRNA Signature for Early… (NCT07266363) | Bored Studies