Personalised Health Recommendations to the General Population Through an Integrated AI Guided

Not Applicable

Recruiting

• Conditions: Helicobacter Pylori Infection; Artificial Intelligence; Gastric Cancer; Cancer Prevention
• Interventions: Behavioral: Health reccommendations

• Registration Number: NCT06421324
• Lead Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

Brief Summary

This clinical study aims to be used to implement and validate the AIDA tool in two phases:

* Phase 1: Risk stratification and personalised recommendations \& Model development

* Phase 2: Mechanistic Model (Bioresource) development \& testing

Detailed Description

The AIDA objective (project) is to develop and validate a multidisciplinary AI-powered assistant that helps clinicians diagnose precancerous inflammation, suggests personalised therapeutic strategies for medical treatment and follow-up, and makes personalised recommendations for monitoring patient health status, thus contributing to gastric cancer prevention. This prospective clinical study aims to implement and validate such tool.

Study Timeline

• Study First Submitted: 2024-05-08
• Study First Submitted QC: 2024-05-17
• Study First Posted: 2024-05-20
• Study Start: 2024-06-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2026-07-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Subjects ≥ 18 years old with a diagnosis of GIM or previous or current H. pylori infection, to whom a gastroscopy is indicated within clinical care
• Availability of a signed informed consent form to participate in the study

Exclusion Criteria

• Patients to whom an endoscopy is performed for the follow-up of another illness such as oesophageal varices and/or for therapy such as endoscopic dilation, feeding tube placement or endoscopic resection
• Subjects with a clinical diagnosis of gastric diseases other than GIM or GC
• Patients who have received antimicrobials during the four weeks prior to the endoscopy
• Patients who have received proton pump inhibitors and/or bismuth-based treatments at least two weeks prior to the endoscopy
• Subjects for whom clinical data are not available: H. pylori status, eradication treatment, sex, age, tobacco smoking, and first-degree family history of gastric cancer
• Subjects who lack the mental capacity to understand the nature and requirements of the study and who lack the ability to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GIM cases	Health reccommendations	Subjects will be recruited prospectively from the Digestive Medicine/Endoscopy Departments of the centres involved. Patients will be treated according to the medical and patient decisions according to the clinical practice protocols of each site. Sample collection will be performed during a gastroscopy for pathological and molecular characterisation. This gastroscopy will be always indicated within usual clinical practice, so no additional risk is planned for the subjects included. Inclusion criteria: Subjects ≥18 years old with a diagnosis of GIM or previous or current H. pylori infection, to whom a gastroscopy is indicated within clinical care

Primary Outcome Measures

Name	Time	Method
H. pylori Eradication Therapy Recommendation	From 30 days after the H.Pylori positive test result to one year after the first recommendation	AI driven H. pylori Eradication Therapy Recommendation
GIM risk score assessment using imaging modalities	At the recruitment stage	AI driven GIM risk score assessment of pre-cancerous lesions using imaging modalities based on: QLQ C30 and STO22 EORTC questionnaire, Healthy lifestyle questionnaire (adapted from EPICs), Baseline clinical data, If H. pylori positive: adherence to treatment: yes/no; eradication yes/no, If GIM: adherence to follow-up guidelines yes/no
Risk of developing Gastric Cancer based on medical records	At the recruitment stage	Scoring patients as low (\>30) / medium / high risk (\<6) according to: * Degree of 'healthiness' of lifestyle (1 to 10, with 10 as very low and 10 as very high); * Co-morbidities (Yes = 1 / No = 5); * H. pylori infection history (Yes = 1 / No = 5); * Previous gastric intestinal metaplasia (Yes = 1 / No = 5); * Dysplasia or atrophy related to chronic gastritis (Yes = 1 / No = 5); * Family history of cancer (Yes = 1 / No = 5)

Trial Locations

Locations (1)

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain