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GAIN Project: Gastric Cancer and Artificial Intelligence

Study acronym: GAIN
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 4, 2024 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Start date: Mar 2024 to Jun 10, 2024
    • Primary completion date: Mar 2026 to Jun 2026
    • Study completion date: Mar 2028 to Jun 2028
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06275997
Lead Sponsor Istituto Clinico Humanitas
Conditions
(from sponsor)		 Gastric Cancer
Related terms Stomach Neoplasms
Enrollment 6,600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov