Gastric Cancer and Artificial Intelligence: a National-level Project
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6,600
- 主要终点
- Miss rate reduction
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Miss rate reduction
时间窗: 2025: 12 months enrollment
change of the miss rate of early gastric cancer and dysplastic lesions at upper-endoscopy when using AI-assistance (tandem).
次要结局
- patient satisfaction(2025: during the 12 months enrollment)
- Change number of Detections(1 day procedure and follow up for 2 years)
