Detection of Minimal Residual Disease Using Exosomal miRNA Distant Metastasis Markers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: small RNA-seq or array, ENLIGHT Assay.
- Who it may be relevant to
- Registry conditions: Gastric Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exosomal microRNA-based Analysis for Early detectIon of Gastric Cancer Hidden-recurrence Traces
Overview
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.
Interventions
- Diagnostic test small RNA-seq or array
small RNA-seq or array - Diagnostic test ENLIGHT Assay
RT-qPCR-based exo-miRNA quantification
Primary outcome measures
- Recurrence-Free Survival (RFS) [Time frame: up to 5 years]
Secondary outcome measures (1)
- Overall Survival (OS) [Time frame: up to 5 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- City of Hope Medical Center — Duarte
Identifiers
NCT: NCT07243015 · 23228/DESTINEX-REMNANT