Personalised Health Recommendations to the General Population Through an Integrated AI Guided
Interventional Study Focused on Providing Personalised Health Recommendations to the General Population Through an Integrated AI Guided App as a Strategy for Gastric Cancer Prevention (AIDA)
Fundación para la Investigación del Hospital Clínico de Valencia
450 participants
Jun 1, 2024
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria2
- 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 Criteria6
- 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
Interventions
Patients are given recommendations according to their risk group, based on the model which already predicted health indicators. This information will be sent to the patient's treating physician so that treatment and recommendations are aligned with the clinical care practice based on the European Code of Cancer guidelines, the H. pylori best practices guidelines and European GIM guidelines
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06421324