RecruitingNot Applicable

Detection of Minimal Residual Disease Using Exosomal miRNA Distant Metastasis Markers

United States500 participantsStarted 2025-01-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recurrence-Free Survival (RFS)

Timeframe: up to 5 years

Trial details

NCT IDNCT07243015

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-06-18

Contact for this trial

Ajay Goel, PhD

626-218-3452 ajgoel@coh.org

View on ClinicalTrials.gov More Gastric Cancer trials