An observational study in Gastric Cancer, sponsored by City of Hope Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by City of Hope Medical Center · Observational
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.
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
Ultimately, the ENLIGHT assay aims to guide postoperative adjuvant chemotherapy by stratifying patients according to MRD status, enabling precision surveillance and early intervention.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 500 is above the median of 274 across 670 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who underwent curative-intent gastrectomy for gastric adenocarcinoma, with available pre- and postoperative plasma samples.
Exclusion Criteria:
Patients with postoperative distant metastasis; used for biomarker discovery via small RNA sequencing.
Diagnostic Test: small RNA-seq or array
Patients without postoperative metastasis; used as reference controls in discovery phase.
Diagnostic Test: small RNA-seq or array
Patients exhibiting postoperative recurrence within 12 months.
Diagnostic Test: ENLIGHT Assay
Patients without recurrence ≥12 months postoperatively.
Diagnostic Test: ENLIGHT Assay
Independent validation cohort with confirmed distant metastasis or MRD positivity.
Diagnostic Test: ENLIGHT Assay
Independent validation cohort without recurrence/metastasis.
Diagnostic Test: ENLIGHT Assay
small RNA-seq or array
RT-qPCR-based exo-miRNA quantification
Recurrence-Free Survival (RFS)
Time from surgery to recurrence or death.
Time frame: up to 5 years
Overall Survival (OS)
Time from surgery to death from any cause
Time frame: up to 5 years
Plan to share: No — Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data
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City of Hope Medical Center