Blood test combining cell-free and exosomal microRNAs for early detection of esophageal squamous cell carcinoma
Official title: SYNERGY Study: Early Detection Through Integrated Evaluation of Cell-Free and Exosomal microRNAs for Biomarker-Guided Screening of Esophageal Squamous Cell Carcinoma
Run by City of Hope Medical Center · NCT07266363 · Data updated 2026-11-12
This project will try a blood test that measures cell-free and exosomal microRNAs to find early esophageal squamous cell carcinoma in adults using plasma or serum samples.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | City of Hope Medical Center Academic / other |
| Locations | 1 site (Monrovia, California) |
| Status | Recruiting |
| Started | January 15, 2025 |
| Main results expected | June 18, 2028 |
| Study ends | June 18, 2028 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT07266363 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (ages 18–90) with histologically confirmed esophageal squamous cell carcinoma who have not received systemic therapy before blood collection, plus matched control participants without malignant disease for validation cohorts.
✕Probably not a fit
Patients who have received prior systemic therapy, have another recent cancer within five years (except localized cancers as allowed), have active systemic inflammation, or provide inadequate sample volume or RNA quality are unlikely to benefit from this assay.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The SYNERGY program collects preoperative plasma or serum from adults with histologically confirmed ESCC and non-cancer controls and performs small RNA sequencing followed by RT-qPCR to identify and validate circulating microRNA signatures. The approach integrates tumor-specific exosomal miRNAs with broader cell-free miRNA signals to build a diagnostic model. Work proceeds through discovery, training, and independent validation phases to test sensitivity and specificity for early-stage disease. Samples and assays are processed at City of Hope using standardized protocols and a PCR-based SYNERGY assay for validation.
Why it matters
Potential benefit: If successful, this could provide a minimally invasive blood test to detect ESCC at an earlier, more treatable stage, potentially reducing the need for invasive procedures and improving outcomes.
How similar studies have gone: Prior small-scale liquid-biopsy miRNA studies have shown promising signals but lacked large, blood-based validation cohorts, so integrating cf- and exosomal miRNAs is a promising but not yet widely validated approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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City of Hope Medical Center
Monrovia, California, United States Recruiting
Study contacts
- Principal investigator: Ajay Goel, PhD — City of Hope Medical Center
- Study coordinator: Ajay Goel, PhD
- Email: ajgoel@coh.org
- Phone: 626-218-3452
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.