Blood test using exosomal microRNA to find tiny leftover gastric cancer after surgery
Official title: Exosomal microRNA-based Analysis for Early detectIon of Gastric Cancer Hidden-recurrence Traces
Run by City of Hope Medical Center · NCT07243015 · Data updated 2026-11-12
This study tests a blood-based exosomal microRNA assay to see if it can detect minimal residual gastric cancer after curative surgery and predict future distant metastasis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Duarte, California) |
| Status | Recruiting |
| Started | January 15, 2025 |
| Main results expected | June 18, 2028 |
| Study ends | June 18, 2028 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07243015 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with histologically confirmed gastric adenocarcinoma who underwent curative-intent (R0) resection and have available pre- and postoperative plasma samples and follow-up data.
✕Probably not a fit
Patients with metastatic disease at diagnosis, those without adequate plasma samples or RNA quality, or those with synchronous additional malignancies 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 trial develops and validates an exosomal microRNA (exo-miRNA) liquid biopsy called the ENLIGHT assay to detect minimal residual disease after R0 gastrectomy. A discovery phase uses comprehensive small RNA sequencing to identify miRNAs linked to distant metastasis, followed by a training phase that quantifies candidate exo-miRNAs by RT-qPCR to create an MRD signature. A separate validation cohort then tests the diagnostic performance, sensitivity, and specificity of the exosomal MRD panel in postoperative plasma. The goal is to use this assay to stratify patients for adjuvant chemotherapy and enable earlier, more precise surveillance.
Why it matters
Potential benefit: If successful, the assay could identify occult residual disease earlier than imaging, allowing targeted adjuvant therapy and closer surveillance to reduce metastatic recurrence risk.
How similar studies have gone: Circulating tumor DNA MRD assays have shown promise in several cancers including some gastric cancer cohorts, but exosomal miRNA approaches are relatively novel and have only preliminary supporting data so far.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed gastric adenocarcinoma. * Underwent curative-intent resection (R0). * Availability of pre- and postoperative plasma samples. * Documented clinical follow-up data (recurrence/metastasis status). * Provided written informed consent. Exclusion Criteria: * Insufficient plasma volume or RNA quality for exosomal extraction. * Presence of synchronous or metachronous malignancies. * Received neoadjuvant chemotherapy without postoperative follow-up. * Lack of consent or incomplete clinicopathologic data.
Where it's running
-
City of Hope Medical Center
Duarte, California, United States Recruiting
Study contacts
- 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.