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

NCT06421324 | Recruiting DMC

• 1 other identifier: AIDA_HE
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

Healthy controls

NO INTERVENTION

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

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

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

Behavioral: Health reccommendations

Interventions

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

GIM cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (1)

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

Related Links

• Website

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Tania Fleitas, MD, PhD

  Fundación para la Investigación del Hospital Clínico de Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Miralles Marco, PhD

CONTACT

+34 689567412; amiralles@incliva.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 20, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)