GAIN Project: Gastric Cancer and Artificial Intelligence
- Conditions
- Gastric Cancer
- Interventions
- Device: Integration of Artificial Intelligence (AI) assistance to screening gastroscopy
- Registration Number
- NCT06275997
- Lead Sponsor
- Istituto Clinico Humanitas
- Brief Summary
Our GAIN 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 6600
- All >60 years-old patients undergoing upper-gastrointestinal (GI) endoscopy for selected indications in Italian areas at high-risk of gastric cancer (Lombardia, Emilia Romagna, Veneto, Friuli-Venezia Giulia).
- contraindications to upper-GI endoscopy.
- contraindications to biopsy.
- active upper-GI bleeding or urgent upper-GI endoscopy.
- patients with previous upper-GI surgery involving the stomach.
- patients who were not able or refused to give informed written consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Parallel arm 2 Integration of Artificial Intelligence (AI) assistance to screening gastroscopy patients will undergo high-definition and high quality upper-GI endoscopy with real-time assistance by real-time artificial intelligence for the detection of early gastric cancer and gastric dysplasia. Cross-over arm 1 (control) Integration of Artificial Intelligence (AI) assistance to screening gastroscopy patients will undergo two standard high-definition and high-quality upper-GI endoscopies in tandem: the first will be without Artificial Intelligence assistance, and the second with Artificial Intelligence in order to define the miss rate for standard unassisted upper-GI endoscopy. Cross-over arm 2 Integration of Artificial Intelligence (AI) assistance to screening gastroscopy patients will undergo two standard high-definition and high-quality upper-GI endoscopies in tandem: the first will be with Artificial Intelligence assistance, and the second without Artificial Intelligence in order to define the decrease of miss rate when assistance by Artificial Intelligence is implemented.
- Primary Outcome Measures
Name Time Method Miss rate reduction 2025: 12 months enrollment change of the miss rate of early gastric cancer and dysplastic lesions at upper-endoscopy when using AI-assistance (tandem).
- Secondary Outcome Measures
Name Time Method patient satisfaction 2025: during the 12 months enrollment Assessment of patient acceptability, satisfaction and tolerance, assessed by questionnaire, towards AI technology for both the detection and the characterization of gastric lesions.
Change number of Detections 1 day procedure and follow up for 2 years Change in the detection of early gastric cancer and dysplastic lesions at upper-endoscopy when using AI-assistance (parallel).