Study Design
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VISTA is a prospective, multicenter screening study conducted across four European hospitals, with centralized epidemiological and AI support. The study will run during 36 months.
Screening Arms
Arm A – Primary Transnasal Endoscopy Screening
• Pedro Hispano Hospital, ULS Matosinhos (Portugal): 2,000 TNE procedures
• Navarra University Hospital, Pamplona (Spain): 2,000 TNE procedures
Participants will undergo unsedated, high definition transnasal upper GI endoscopy as a
primary screening test.
Arm B – Opportunistic Gastric Screening within CRC Programs
• Braga University Hospital (Portugal): 1,000 gastroscopies
• Hospital Clínic Barcelona (Spain): 1,000 gastroscopies
Participants already scheduled for colonoscopy under organized CRC screening programs will undergo conventional gastroscopy during the same sedated session.
Total planned sample size: 6,000 participants
Study Population
Inclusion Criteria
• Adults eligible for population-based cancer screening
• Asymptomatic individuals
• Ability to provide informed consent
Exclusion Criteria
• Previous gastric cancer diagnosis
• Prior major gastric surgery
• Contraindications to endoscopy
Procedures and Data Collection
All centers will follow harmonized protocols, derived from prior multicenter screening experience.
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Endoscopic Assessment
• Systematic gastric inspection using high-definition white light and virtual chromoendoscopy
• Standardized image and video acquisition
• Targeted biopsies of suspicious lesions according to ESGE recommendations
Data Collection
• Demographics: age, sex
• Clinical variables: smoking status, relevant comorbidities, family history
• Endoscopic findings and histopathology results
Artificial Intelligence and Screening Optimization
AI represents a central innovation of VISTA. Using curated endoscopic image and video datasets, AI models will be developed to:
• Detect gastric premalignant and malignant lesions
• Provide objective quality metrics for gastric inspection
• Integrate endoscopic findings with clinical and demographic data to support riskstratified screening strategies
AI tools will function as decision-support systems, enhancing—but not replacing—clinical judgment.
Outcomes
Primary Outcomes
• Completion and safety rates of transnasal endoscopy
Secondary Outcomes
• Patient tolerance and acceptability
• Detection rate of gastric cancer and advanced premalignant lesions
• Comparative diagnostic yield between screening arms
• AI performance metrics (sensitivity, specificity)
• Operational indicators relevant to scalability and cost-effectiveness
Ethics, Data Protection, and Compliance
The study will comply with:
• Declaration of Helsinki
• GDPR and EU data-protection regulations
• National and institutional ethics approvals
All participants will provide written informed consent. Data will be anonymized and securely stored within EU-based infrastructures.
Expected Impact
VISTA directly supports EU4Health priorities by:
• Advancing early cancer detection through innovative, low-burden screening strategies.
• Leveraging AI to improve quality, efficiency, and equity of preventive care.
• Generating real-world evidence to inform future European gastric cancer screening policies.
• Providing a scalable model adaptable to other intermediate-risk regions in Europe.
By building on validated epidemiological frameworks and translational experience, VISTA aims to accelerate the transition from opportunistic detection to structured, data-driven gastric cancer prevention in Europe.