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

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

NCT ID: NCT06421324

Condition: Gastric Cancer
Cancer Prevention
Helicobacter Pylori Infection
Artificial Intelligence

Conditions: Official terms:
Stomach Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Intervention model description: In practice, for rare diseases we chose a sample size that will allow estimation of sensitivity of the risk score to a pre-specified precision. We have chosen the sample size assuming that the resulting precancer detection model will have a sensitivity of at least 85%, and so that the lower 95% confidence interval will exceed 76%, with 80% power. The R package MKmisc estimates sample size for a proportion based on the Binomial distribution rather than a Normal approximation. In this case, we have estimated a sample size of 141 GIM + cancer and 141 GIM controls (282 in total). With 5% of samples assumed to be failing to be analysed due to a variety of technical reasons, we would need ~300 samples in total. In addition, to train the system 150 gastric cancer cases will be recruited which will provide pathology samples images and endoscopy images that will be taken as part of the clinical practice.

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Health reccommendations
Description: 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
Arm group label: GIM cases

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

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Hospital Clínico Universitario de Valencia

Address:
City: Valencia
Zip: 46010
Country: Spain

Start date: June 1, 2024

Completion date: December 31, 2026

Lead sponsor:
Agency: Tania Fleitas Kanonnikoff
Agency class: Other

Source: Fundación para la Investigación del Hospital Clínico de Valencia

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06421324
https://www.aidaeuproject.org/