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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ajay Goel
- Número de teléfono: 626-256-4673
- Correo electrónico: ajgoel@coh.org
Ubicaciones de estudio
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California
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Duarte, California, Estados Unidos, 91016
- Reclutamiento
- City of Hope Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Treatment response based on 3-year recurrence-free survival
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Diagnostic performance of the predictive model
Periodo de tiempo: 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
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 23228/VERSA
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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