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

Gastric Cancer Clinical Trial

— AIDA  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06421324
• Other study ID #: AIDA_HE
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: Ana Miralles Marco, PhD
• Phone: +34 689567412
• Email: amiralles[@]incliva.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: December 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Artificial Intelligence
• Cancer Prevention
• Gastric Cancer
• Helicobacter Pylori Infection
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Tania Fleitas Kanonnikoff

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of developing Gastric Cancer based on medical records	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)	At the recruitment stage
Primary	H. pylori Eradication Therapy Recommendation	AI driven H. pylori Eradication Therapy Recommendation	From 30 days after the H.Pylori positive test result to one year after the first recommendation
Primary	GIM risk score assessment using imaging modalities	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	At the recruitment stage

External Links

•   Website