Alternative Splicing Based Prediction of Chemotherapy Response in Gastric Cancer
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)
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Ajay Goel
- 电话号码：626-256-4673
- 邮箱：ajgoel@coh.org
学习地点
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California
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Duarte、California、美国、91016
- 招聘中
- City of Hope Medical Center
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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)
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Responder
Patients with stage II/III gastric cancer who did not develop recurrence within 3 years after curative surgery following adjuvant chemotherapy.
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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.
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Non-responder
Patients with stage II/III gastric cancer who developed recurrence within 3 years after curative surgery following adjuvant chemotherapy.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Treatment response based on 3-year recurrence-free survival
大体时间：3 years after surgery
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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.
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3 years after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Diagnostic performance of the predictive model
大体时间：At model evaluation
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Model performance was assessed using the area under the receiver operating characteristic curve, sensitivity, and specificity in the training and validation cohorts.
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At model evaluation
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Recurrence-free survival stratified by predefined model-derived risk score
大体时间：Up to 5 years after surgery
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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.
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Up to 5 years after surgery
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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