Alternative Splicing Based Prediction of Chemotherapy Response in Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational study (no intervention).
- Who it may be relevant to
- Registry conditions: Gastric Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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.
Interventions
- Other Observational study (no intervention)
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.
Primary outcome measures
- Treatment response based on 3-year recurrence-free survival [Time frame: 3 years after surgery]
Secondary outcome measures (2)
- Diagnostic performance of the predictive model [Time frame: At model evaluation]
- Recurrence-free survival stratified by predefined model-derived risk score [Time frame: Up to 5 years after surgery]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- City of Hope Medical Center — Duarte
Identifiers
NCT: NCT07587229 · 23228/VERSA