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

Fundación para la Investigación del Hospital Clínico de Valencia

Status: Enrolling

Conditions: Gastric Cancer; Artificial Intelligence; Helicobacter Pylori Infection; Cancer Prevention

Treatments: Behavioral: Health reccommendations

Study type: Interventional

Funder types: Other

Identifiers

NCT06421324

AIDA_HE

Details and patient eligibility

About

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

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 3 patient groups

Healthy controls

No Intervention group

Description:

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 to whom an endoscopy is performed due to gastric symptoms, without previous history of gastric chronic inflammation or Helicobacter pylori infection

Gastric cancer controls

No Intervention group

Description:

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 Gastric Cancer, to whom a gastroscopy is indicated within clinical care naive for chemotherapy.

GIM cases

Experimental group

Description:

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

Treatment:

Behavioral: Health reccommendations