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临床试验/NCT06275997
NCT06275997尚未招募不适用

Gastric Cancer and Artificial Intelligence: a National-level Project

Istituto Clinico Humanitas0 个研究点目标入组 6,600 人开始时间: 2024年6月10日最近更新:
适应症

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

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)

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

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