Clinical trial · Observational
Deciphering the Molecular Traits of Non-canonical Responders to Advance Personalized Therapy in Gastric Cancer
NCT06877910CI-TRIAL-00087255active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Retrospective-prospective observational study in which a novel whole-exome sequencing (WES) approach will be used in association with whole-transcriptome sequencing (WTS) to analyze two independent and equally sized cohorts of patients with mGC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Retrospective, identification set
- description
- A workflow based on numerous statistical analyses will assign the individual molecular outcomes in one of the three categories considered (exceptional responders, conventional responders, fast progressors). The information retrieved with this first level of analysis will be summarized in a single tool for the prediction of individual risk (nomogram). In order to guarantee reproducibility, the prognostic classifier will be obtained from a retrospective cohort of patients with mGC treated with standard first-line chemotherapy.
- label
- Prospective, validation set
- description
- Definition of the evolutionary trajectories of atypical responders mGC, by taking blood samples from patients enrolled in the prospective cohort, collected at predefined time points. The serial collection of blood samples will allow the study of circulating nucleic acids (cfTNA, liquid biopsy) for the monitoring of genomic alterations and for the levels of gene expression differentially represented in exceptional responders and fast progressors.
Primary outcomes (1)
- measure
- Progression-free survival PFS
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years; * Histological diagnosis of locally advanced or metastatic gastric cancer (GC) or gastroesophageal junction carcinoma (EJC); * Adequate biological material for molecular analysis, collected (at surgery or by biopsy) before the administration of any anti-tumor treatment (chemotherapy and/or radiotherapy); * ECOG PS 0-2; * Adequate hematological, hepatic and renal function; * Measurable disease according to RECIST criteria; * Written informed consent. Exclusion Criteria: * Previous chemotherapy for metastatic disease; * Comorbidities not controlled with adequate medical therapy; * Brain metastases; * Patient unable to give adequate consent to the study.
References
Publications (0)
Data not yet available
No reference posted for this study.