Exosomal microRNA-based Analysis for Early detectIon of Gastric Cancer Hidden-recurrence Traces
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
City of Hope Medical Center
RECRUITING
Duarte
Contact Information
Primary
Ajay Goel, PhD
ajgoel@coh.org
626-218-3452
Time Frame
Start Date: 2025-01-15
Estimated Completion Date: 2026-06-18
Participants
Target number of participants: 500
Treatments
Discovery Cohort - Distant Metastasis Positive
Patients with postoperative distant metastasis; used for biomarker discovery via small RNA sequencing.
Discovery Cohort - Distant Metastasis Negative
Patients without postoperative metastasis; used as reference controls in discovery phase.
Training Cohort - MRD Positive (High Risk)
Patients exhibiting postoperative recurrence within 12 months.
Training Cohort - MRD Negative (Low Risk)
Patients without recurrence ≥12 months postoperatively.
Validation Cohort - MRD Positive
Independent validation cohort with confirmed distant metastasis or MRD positivity.
Validation Cohort - MRD Negative
Independent validation cohort without recurrence/metastasis.
Related Therapeutic Areas
Sponsors
Leads: City of Hope Medical Center