Recruiting

Liquid Biopsy Assay

Sponsor:

City of Hope Medical Center

Code:

NCT07243015

Conditions

Gastric Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

small RNA-seq or array

ENLIGHT Assay

Study Details

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

Study ID

NCT07243015

Start date

Jan 15, 2025

Status verified date

Jul, 2026

Completion date

Jun 18, 2028

Anticipated

Primary completion date

Jun 18, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

small RNA-seq or array

small RNA-seq or array

ENLIGHT Assay

RT-qPCR-based exo-miRNA quantification

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ajay Goel, PhD

626-218-3452ajgoel@coh.org

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91016

Contacts

Ajay Goel, PhD

626-218-3452ajgoel@coh.org

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-07-06.