Detection of Minimal Residual Disease Using Exosomal miRNA Distant Metastasis Markers (ENLIGHT)

November 17, 2025 updated by: City of Hope Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ajay Goel, PhD
  • Phone Number: 626-218-3452
  • Email: ajgoel@coh.org

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91016
        • Recruiting
        • City of Hope Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent curative-intent gastrectomy for gastric adenocarcinoma, with available pre- and postoperative plasma samples.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Discovery Cohort - Distant Metastasis Positive
Patients with postoperative distant metastasis; used for biomarker discovery via small RNA sequencing.
Diagnostic test: small RNA-seq or array
small RNA-seq or array
Discovery Cohort - Distant Metastasis Negative
Patients without postoperative metastasis; used as reference controls in discovery phase.
Diagnostic test: small RNA-seq or array
small RNA-seq or array
Training Cohort - MRD Positive (High Risk)
Patients exhibiting postoperative recurrence within 12 months.
Diagnostic test: ENLIGHT Assay
RT-qPCR-based exo-miRNA quantification
Training Cohort - MRD Negative (Low Risk)
Patients without recurrence ≥12 months postoperatively.
Diagnostic test: ENLIGHT Assay
RT-qPCR-based exo-miRNA quantification
Validation Cohort - MRD Positive
Independent validation cohort with confirmed distant metastasis or MRD positivity.
Diagnostic test: ENLIGHT Assay
RT-qPCR-based exo-miRNA quantification
Validation Cohort - MRD Negative
Independent validation cohort without recurrence/metastasis.
Diagnostic test: ENLIGHT Assay
RT-qPCR-based exo-miRNA quantification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-Free Survival (RFS)
Time Frame: up to 5 years
Time from surgery to recurrence or death.
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: up to 5 years
Time from surgery to death from any cause
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2025

Primary Completion (Estimated)

June 18, 2026

Study Completion (Estimated)

June 18, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23228/ENLIGHT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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