Exosomal microRNA-based Analysis for Early detectIon of Gastric Cancer Hidden-recurrence Traces
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Recurrence-Free Survival (RFS)
Study Overview
Brief 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
- Discovery Phase - Comprehensive small RNA sequencing to identify miRNAs specific to distant metastasis in gastric cancer.
- Training Phase - RT-qPCR-based quantification of candidate exo-miRNAs in postoperative plasma samples to develop an MRD signature.
- 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Discovery Cohort - Distant Metastasis Negative
Patients without postoperative metastasis; used as reference controls in discovery phase.
Intervention: small RNA-seq or array (Diagnostic Test)
Training Cohort - MRD Positive (High Risk)
Patients exhibiting postoperative recurrence within 12 months.
Intervention: ENLIGHT Assay (Diagnostic Test)
Training Cohort - MRD Negative (Low Risk)
Patients without recurrence ≥12 months postoperatively.
Intervention: ENLIGHT Assay (Diagnostic Test)
Validation Cohort - MRD Positive
Independent validation cohort with confirmed distant metastasis or MRD positivity.
Intervention: ENLIGHT Assay (Diagnostic Test)
Validation Cohort - MRD Negative
Independent validation cohort without recurrence/metastasis.
Intervention: ENLIGHT Assay (Diagnostic Test)
Discovery Cohort - Distant Metastasis Positive
Patients with postoperative distant metastasis; used for biomarker discovery via small RNA sequencing.
Intervention: small RNA-seq or array (Diagnostic Test)
Outcomes
Primary Outcomes
Recurrence-Free Survival (RFS)
Time Frame: up to 5 years
Time from surgery to recurrence or death.
Secondary Outcomes
- Overall Survival (OS)(up to 5 years)