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NCT Number: NCT06421324

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

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

Recruiting

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Key information

Conditions

Gastric Cancer Artificial Intelligence Cancer Prevention Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Helicobacter Pylori Infection Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location status: Recruiting

Location contact

Tania Fleitas, MD, PhD

CONTACT

[email protected]

+34 616315091

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health reccommendations

Behavioral

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 outcomes

  1. Risk of developing Gastric Cancer based on medical records

    Time frame: 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)

  2. H. pylori Eradication Therapy Recommendation

    Time frame: From 30 days after the H.Pylori positive test result to one year after the first recommendation

    AI driven H. pylori Eradication Therapy Recommendation

  3. GIM risk score assessment using imaging modalities

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Miralles Marco, PhD

CONTACT

[email protected]

+34 689567412

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Registry information

Official study 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)

Acronym: AIDA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 20, 2024
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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