NCT07243015

Detection of Minimal Residual Disease Using Exosomal miRNA Distant Metastasis Markers

Exosomal microRNA-based Analysis for Early detectIon of Gastric Cancer Hidden-recurrence Traces

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Gastric cancer (GC) is a leading cause of cancer-related death worldwide. Even in patients undergoing curative surgery for non-metastatic disease, postoperative recurrence frequently occurs due to undetected minimal residual disease (MRD). This study aims to establish a highly sensitive and specific liquid biopsy assay using exosomal microRNAs (exo-miRNAs) to detect MRD and predict distant metastasis before clinical recurrence.

Detailed description

Postoperative recurrence in gastric cancer is largely driven by occult micrometastatic disease that remains undetectable by conventional imaging. While circulating tumor DNA (ctDNA) assays have shown utility in MRD detection, their limited sensitivity and tumor-type variability hinder consistent application in gastric cancer. Exosomal microRNAs (exo-miRNAs), encapsulated within lipid bilayer vesicles, remain stable in circulation and reflect tumor-derived molecular information. This study seeks to develop and validate an exosomal miRNA-based signature capable of detecting minimal residual disease and predicting future distant metastasis after curative gastrectomy. Study Phases 1. Discovery Phase - Comprehensive small RNA sequencing to identify miRNAs specific to distant metastasis in gastric cancer. 2. Training Phase - RT-qPCR-based quantification of candidate exo-miRNAs in postoperative plasma samples to develop an MRD signature. 3. Validation Phase - Independent cohort testing to evaluate the diagnostic performance, sensitivity, and specificity of the exosomal MRD panel. Ultimately, the ENLIGHT assay aims to guide postoperative adjuvant chemotherapy by stratifying patients according to MRD status, enabling precision surveillance and early intervention.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	small RNA-seq or array	small RNA-seq or array
DIAGNOSTIC_TEST	ENLIGHT Assay	RT-qPCR-based exo-miRNA quantification

Timeline

• Start date: 2025-01-15
• Primary completion: 2026-06-18
• Completion: 2026-06-18
• First posted: 2025-11-21
• Last updated: 2025-11-21

Locations

1 site across 1 country: United States