Detection of Minimal Residual Disease Using Exosomal miRNA Distant Metastasis Markers

NCT07243015 | Recruiting

• 1 other identifier: 23228/ENLIGHT
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

GC; MRD; Tumor recurrence; Exosomal microRNAs; Gastric cancer

Outcome Measures

Primary Outcomes (1)

• Recurrence-Free Survival (RFS)

  Time from surgery to recurrence or death.

  up to 5 years

Secondary Outcomes (1)

• Overall Survival (OS)

  up to 5 years

Study Arms (6)

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

Discovery Cohort - Distant Metastasis Negative

Patients without postoperative metastasis; used as reference controls in discovery phase.

Diagnostic Test: small RNA-seq or array

Training Cohort - MRD Positive (High Risk)

Patients exhibiting postoperative recurrence within 12 months.

Diagnostic Test: ENLIGHT Assay

Training Cohort - MRD Negative (Low Risk)

Patients without recurrence ≥12 months postoperatively.

Diagnostic Test: ENLIGHT Assay

Validation Cohort - MRD Positive

Independent validation cohort with confirmed distant metastasis or MRD positivity.

Diagnostic Test: ENLIGHT Assay

Validation Cohort - MRD Negative

Independent validation cohort without recurrence/metastasis.

Diagnostic Test: ENLIGHT Assay

Interventions

small RNA-seq or array DIAGNOSTIC_TEST

small RNA-seq or array

Discovery Cohort - Distant Metastasis Negative; Discovery Cohort - Distant Metastasis Positive

ENLIGHT Assay DIAGNOSTIC_TEST

RT-qPCR-based exo-miRNA quantification

Training Cohort - MRD Negative (Low Risk); Training Cohort - MRD Positive (High Risk); Validation Cohort - MRD Negative; Validation Cohort - MRD Positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91016, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Exosomal microRNAs in plasma or serum

MeSH Terms

Conditions

Stomach Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ajay Goel, PhD

CONTACT

626-218-3452; ajgoel@coh.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): June 18, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)