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Recruiting NCT06421324

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

No phase Interventional Gastric Cancer Cancer Prevention Helicobacter Pylori Infection Artificial Intelligence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Health reccommendations.
Who it may be relevant to
Registry conditions: Gastric Cancer, Cancer Prevention, Helicobacter Pylori Infection, Artificial Intelligence. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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)

Overview

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.

Interventions

  • Behavioral Health reccommendations
    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

Primary outcome measures

  • Risk of developing Gastric Cancer based on medical records [Time frame: At the recruitment stage]
  • H. pylori Eradication Therapy Recommendation [Time frame: From 30 days after the H.Pylori positive test result to one year after the first recommendation]
  • GIM risk score assessment using imaging modalities [Time frame: At the recruitment stage]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Spain · 1 center
  • Hospital Clínico Universitario de Valencia — Valencia

Identifiers

NCT: NCT06421324 · AIDA_HE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗