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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Ajay Goel
- Número de telefone: 626-256-4673
- E-mail: ajgoel@coh.org
Locais de estudo
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California
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Duarte, California, Estados Unidos, 91016
- Recrutamento
- City of Hope Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Treatment response based on 3-year recurrence-free survival
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Diagnostic performance of the predictive model
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 23228/VERSA
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