Clinical trial · Observational
InteGRAtive Analysis of TuMor, Microenvironment, ImmunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer
NCT04842916CI-TRIAL-00082812GRAMMYrecruitingClinicalTrials.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)
Multicentric, exploratory, non-pharmacologic, retrospective/prospective, translational study aiming to identify the molecular, cellular and psychological-sociological variables predictive of response to chemotherapy in gastric cancer patients.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Gastric cancer patients
- description
- gastric cancer patients with histologically confirmed, potentially resectable adenocarcinoma of the stomach or the gastroesophageal junction receiving the standard of medical care in Europe
Primary outcomes (5)
- measure
- Genomic alterations in tumoral tissue in responders and non-responders
- timeFrame
- 36 months
- description
- Number of Genomic alterations in tumoral tissue
- measure
- Quantitative and qualitative analysis of the tumor microenvironment composition in responders and non-responders
- timeFrame
- 36 months
- description
- Analysis of type and size of immune cell subpopulations surrounding primary tumor and extracellular matrix composition on FFPE samples collected at diagnosis and/or surgery. Correlation of data acquired to Participant's response score (TRG or DFS).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach (GC) or the gastric-esophageal junction (GEJ) treated with the standard regimens (5-Fluoro-Uracil or Capecitabine + Oxaliplatin +/- Docetaxel) * Participant is willing and able to give informed consent for participation in the study (prospective and retrospective cohort) or Substitutive Informed Consent Declaration Form will be subscribed by the PI for patients that are not reachable * Male or Female, aged \>18 years * Availability of tissue samples and clinico-pathological data for retrospective cohort Exclusion Criteria: * Age \< 18 years * Early Gastric Cancer and T2 (if N0) * Linitis plastica * Positive peritoneal cytology or peritoneal involvement * Distant metastases * Patient refusal to participate * Patient refusal to the use of their own samples for research * Patient withdrawing from treatment plan whilst under therapy due to patient co-morbidities or failure to comply with clinical counselling * Patients with underlying pathologies rendering sampling of biological material either as endangering patient's clinical status or as unusable * Patients with mental illness hindering the capacity to provide precise information in questionnaires or successfully comply with caregiver's recommendations
References
Publications (0)
Data not yet available
No reference posted for this study.