Prediction of chemotherapy response in gastric cancer using RNA splicing
Official title: A Multicenter Observational Study to Develop and Validate an Alternative Splicing-Based Machine Learning Model for Predicting Response to 5-FU-Based Adjuvant Chemotherapy in Gastric Cancer (VERSA-GC Study)
Run by City of Hope Medical Center · NCT07587229 · Data updated 2026-11-12
Researchers will test whether RNA splicing patterns in tumor tissue can predict which gastric cancer patients will respond to 5-FU-based chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 329 (estimated) |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Duarte, California) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | January 1, 2027 |
| Study ends | January 1, 2027 |
| Registry record updated | May 14, 2026 |
| Trial ID | NCT07587229 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with pathologically confirmed stage II or III gastric cancer who had curative surgery and received 5-FU–based adjuvant chemotherapy, with available tumor tissue for analysis.
✕Probably not a fit
Patients whose tumors do not show informative splicing patterns or whose disease biology is driven by non-splicing factors may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational study aims to build and validate a model that uses alternative splicing information from tumor samples to forecast response to adjuvant 5-FU therapy in stage II/III gastric cancer. The team identifies splicing events from TCGA SpliceSeq and UCSC Xena, quantifies candidates by RT-qPCR, and creates an Elastic Net–selected plus XGBoost predictive model. An integrated model that includes clinicopathological data is also developed and evaluated in independent cohorts. The primary endpoint is recurrence-free survival at 3 years, classifying patients as responders or non-responders based on recurrence status. The goal is to establish a clinically applicable biomarker to guide treatment decisions.
Why it matters
Potential benefit: If successful, the model could help physicians personalize chemotherapy decisions and potentially spare some patients from ineffective treatment.
How similar studies have gone: Previous work using genomic and transcriptomic data has shown promise in predicting chemotherapy response in various cancers, but this specific AS-based approach in gastric cancer is exploratory and not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically confirmed stage II or III gastric cancer * Underwent curative surgical resection * Received 5-FU-based adjuvant chemotherapy * Availability of tumor tissue samples for analysis Exclusion Criteria: * History of other malignancies * Inadequate or poor-quality tissue samples (e.g., contamination)
Where it's running
-
City of Hope Medical Center
Duarte, California, United States Recruiting
Study contacts
- Study coordinator: Ajay Goel
- Email: ajgoel@coh.org
- Phone: 626-256-4673
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.