Blood test using exosomal microRNA to find tiny leftover gastric cancer after surgery
Exosomal microRNA-based Analysis for Early detectIon of Gastric Cancer Hidden-recurrence Traces
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT07243015 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Duarte, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.