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NCT07587229Recruiting

Alternative Splicing Based Prediction of Chemotherapy Response in Gastric Cancer

City of Hope Medical Center

Start Date

5/1/2026

Completion Date

1/1/2027

Summary

This study aims to develop a model to predict response to chemotherapy in gastric cancer using RNA splicing information from tumor tissue. By analyzing genetic patterns and applying machine learning, the study seeks to identify patients who are less likely to benefit from treatment, helping guide clinical decision-making.

Detailed Description

This multicenter observational study aims to develop and validate an alternative splicing (AS)-based model to predict response to 5-FU-based adjuvant chemotherapy in stage II/III gastric cancer. AS events were identified using TCGA SpliceSeq and UCSC Xena data, and selected candidates were quantified by RT-qPCR. A predictive model was constructed using Elastic Net-based feature selection and XGBoost, and evaluated in independent training and validation cohorts. An integrated model incorporating clinicopathological factors was also developed. The primary endpoint is treatment response defined by 3-year recurrence-free survival. Patients with recurrence within 3 years are classified as non-responders, and those without recurrence as responders. This study aims to establish a clinically applicable biomarker for risk stratification and treatment decision support.

Eligibility Criteria

Age Range: 18 years to No maximum

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)

Interventions

OTHER

Observational study (no intervention)

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Conditions

Gastric Cancer

Locations

City of Hope Medical Center

Duarte, California 91016

United States