Detection of Minimal Residual Disease Using Exosomal miRNA Distant Metastasis Markers

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07243015
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • small RNA-seq or array — DIAGNOSTIC_TEST
    small RNA-seq or array
  • ENLIGHT Assay — DIAGNOSTIC_TEST
    RT-qPCR-based exo-miRNA quantification

Study Details

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.

Key Dates

Start date
Jan 15, 2025
Status verified
Nov 2025
Primary completion
Jun 18, 2026
Completion
Jun 18, 2026

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Discovery Cohort - Distant Metastasis Positive
    Patients with postoperative distant metastasis; used for biomarker discovery via small RNA sequencing.
  • Arm: Discovery Cohort - Distant Metastasis Negative
    Patients without postoperative metastasis; used as reference controls in discovery phase.
  • Arm: Training Cohort - MRD Positive (High Risk)
    Patients exhibiting postoperative recurrence within 12 months.
  • Arm: Training Cohort - MRD Negative (Low Risk)
    Patients without recurrence ≥12 months postoperatively.
  • Arm: Validation Cohort - MRD Positive
    Independent validation cohort with confirmed distant metastasis or MRD positivity.
  • Arm: Validation Cohort - MRD Negative
    Independent validation cohort without recurrence/metastasis.

Primary Outcome Measure

Recurrence-Free Survival (RFS) [ Time Frame: up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91016
Ajay Goel, PhD
[email protected]
626-218-3452

Find similar trials in Duarte, CA

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
City of Hope Medical Center· Duarte, CA

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