Clinical trial · Interventional
Artificial Intelligence to Solve the MissINg of Gastric Cancer (AIMING)
Gastric Cancer and Artificial Intelligence: a National-level Project
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Integration of Artificial Intelligence (AI) assistance to screening gastroscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Parallel arm 1
- description
- patients will undergo standard high-definition and high-quality upper-GI endoscopy for the detection of gastric lesions with histological mapping according to Sydney system
- type
- ACTIVE_COMPARATOR
- label
- Parallel arm 2
- description
- 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.
- interventionNames
- Device: Integration of Artificial Intelligence (AI) assistance to screening gastroscopy
- type
- OTHER
- label
- Cross-over arm 1 (control)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * All \>60 years-old patients undergoing upper-gastrointestinal (GI) endoscopy for selected indications at high-risk of gastric cancer.. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available