Clinical trial · Observational
Advanced GC Multi-omic Characterization in EU and CELAC Populations
NCT04015466CI-TRIAL-00076962LEGACY-2completedClinicalTrials.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)
Observational study (cohort type) of advanced GC patients that will be recruited prospectively to study biological factors associated with the disease and relevant clinical outcomes.
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 (2)
- label
- Cases
- description
- Patients with high diagnostic suspicion of advanced GC diagnosis
- label
- Control
- description
- Patients with confirmed absent of GC
Primary outcomes (1)
- measure
- Development of a new diagnostic algorithm for gastric cancer that includes molecular landscape, patient history, histopathological and environmental factors, personal microbiome and immune landscape
- timeFrame
- 3 years
- description
- The project will look for an integrative diagnostic algorithm that incorporates multi-parameter inputs and apply artificial intelligence to provide more personalized risk estimates and which will form the basis for future development of a clinical tool
Secondary outcomes (7)
- measure
- Proteomic analysis of gastric cancer tissue
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Cases: * Inclusion criteria: * Subjects ≥18 years old. * GC diagnosis stages III and IV (including gastroesophageal junction cancer) and/or a gastroscopy indication due to the high diagnostic suspicion of GC as part of the study of his disease. * Has given and signed the IC to participate in this study. * Exclusion criteria: • Patients diagnosed with GC early disease (stage I and II) suitable for resectable strategy. * Withdrawal criteria: * Patients initially recruited with high suspicion of GC diagnosis but not confirmed by the pathological report. Controls: * Inclusion criteria (only for microbiome analysis): * Subjects ≥18 years old. * Subjects to whom a gastroscopy is indicated within clinical care and is confirmed absent of GC in the same centres will be matched in age (+/- 10 years), gender and pertaining from the same region of the GC case. * Has given and signed the IC to participate in this study. * Exclusion criteria: * Subjects from a different geographic area from the cases. * Patients with high suspicion of GC. * Patients with previous histopathologic diagnosis of peptic (gastric or duodenal) ulcer disease and/or atrophy or intestinal metaplasia. * Patients that have received antimicrobials during the 4 weeks period prior to the endoscopy. * Patients that have received proton pump inhibitors or H2-receptor antagonists, at least 2 weeks prior to the endoscopy
References
Publications (1)
- DERIVEDvan Schooten TS, Derks S, Jimenez-Marti E, Carneiro F, Figueiredo C, Ruiz E, Alsina M, Molero C, Garrido M, Riquelme A, Caballero C, Lezcano E, O'Connor JM, Esteso F, Farres J, Mas JM, Lordick F, Vogt J, Cardone A, Girvalaki C, Cervantes A, Fleitas T; members of LEGACy consortium. The LEGACy study: a European and Latin American consortium to identify risk factors and molecular phenotypes in gastric cancer to improve prevention strategies and personalized clinical decision making globally. BMC Cancer. 2022 Jun 13;22(1):646. doi: 10.1186/s12885-022-09689-9. PMID 35692051