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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Responder | Patients with stage II/III gastric cancer who did not develop recurrence within 3 years after curative surgery following adjuvant chemotherapy. |
| |
| Non-responder | Patients with stage II/III gastric cancer who developed recurrence within 3 years after curative surgery following adjuvant chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study (no intervention) | Other | This is an observational study without assigned interventions. All patients received standard-of-care 5-FU-based adjuvant chemotherapy, and no experimental intervention was performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response based on 3-year recurrence-free survival | Treatment response was defined based on recurrence-free survival (RFS). Patients who developed recurrence within 3 years after curative surgery were classified as non-responders, whereas those without recurrence were classified as responders. | 3 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of the predictive model | Model performance was assessed using the area under the receiver operating characteristic curve, sensitivity, and specificity in the training and validation cohorts. | At model evaluation |
| Recurrence-free survival stratified by predefined model-derived risk score |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with stage II and III gastric cancer who underwent curative resection and received 5-FU-based adjuvant chemotherapy across multiple institutions.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ajay Goel | Contact | 626-256-4673 | ajgoel@coh.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Recruiting | Duarte | California | 91016 | United States |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Tumor tissue samples were used for RNA extraction and alternative splicing analysis
Recurrence-free survival will be evaluated according to the predefined model-derived risk score using Kaplan-Meier survival analysis and Cox proportional hazards models. Recurrence status within 3 years after surgery will be used to define treatment response. |
| Up to 5 years after surgery |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |