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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorIstituto Clinico Humanitas

About this trial

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).

Eligibility criteria

Qualifiers

All >60 years-old patients undergoing upper-gastrointestinal (GI) endoscopy for selected indications at high-risk of gastric cancer..

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Integration of Artificial Intelligence (AI) assistance to screening gastroscopy

Treatment groups

6,600 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators