Clinical Trial

Artificial Intelligence to Solve the MissINg of Gastric Cancer (AIMING)

Study acronym: GAIN
Not Yet Recruiting
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Summary
Our AIMING project comprises four core work packages (WPs): WP1. Nation-level randomized controlled trial; WP2. Development of an innovative AI tool; WP3. Novel microsimulation modelling; WP4. Patient inclusion. The nation-level multi-center tandem randomized controlled trial (WP1) will contribute to a better understanding of how the real-time AI algorithm can reduce miss rate of early gastric cancer and dysplasia during gastroscopy. Moreover, the innovation project will contribute to development of a novel AI tool (WP2) that can stratify the risk of gastric cancer by identifying in vivo precancerous conditions. Furthermore, a microsimulation modelling will allow us to predict how the use of AI can prevent gastric cancer and affect cost and patients' burdens. The assessment of the balance between benefits and harms is quite crucial especially for this type of medical device because the value of innovative tools is sometimes overestimated due to stakeholders' enthusiasm (WP3). Finally, we will take care of patients' perspective throughout the study project by including patient organization in both WP1, 2, and 3 (WP4).
Trial Details
NCT Number NCT06971471
Lead Sponsor Istituto Clinico Humanitas
Conditions Gastric Cancer
Enrollment 6,600 participants
Start Date 2025-06-10
Primary Completion 2027-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2025-05-14