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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Ajay Goel
- Telefonnummer: 626-256-4673
- E-post: ajgoel@coh.org
Studieorter
-
-
California
-
Duarte, California, Förenta staterna, 91016
- Rekrytering
- City of Hope Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Responder
Patients with stage II/III gastric cancer who did not develop recurrence within 3 years after curative surgery following adjuvant chemotherapy.
|
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.
|
|
Non-responder
Patients with stage II/III gastric cancer who developed recurrence within 3 years after curative surgery following adjuvant chemotherapy.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Treatment response based on 3-year recurrence-free survival
Tidsram: 3 years after surgery
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diagnostic performance of the predictive model
Tidsram: At model evaluation
|
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
Tidsram: Up to 5 years after surgery
|
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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 23228/VERSA
Plan för individuella deltagardata (IPD)
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