## Protocol Section
### Identification Module
**NCT ID:** NCT06421324

**Acronym:** AIDA

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

**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)

#### Organization Study ID Info
**ID:** AIDA_HE
#### Organization
**Class:** OTHER
**Full Name:** Fundación para la Investigación del Hospital Clínico de Valencia
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-07-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Tania Fleitas Kanonnikoff

#### Responsible Party

**Investigator Affiliation:** Fundación para la Investigación del Hospital Clínico de Valencia

**Investigator Full Name:** Tania Fleitas Kanonnikoff

**Investigator Title:** MD, PhD

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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

**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.

### Conditions Module

**Conditions:**

- Gastric Cancer

- Cancer Prevention

- Helicobacter Pylori Infection

- Artificial Intelligence

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

**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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 450

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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

**Label:** Healthy controls

**Type:** NO_INTERVENTION

#### Arm Group 2

**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.

**Label:** Gastric cancer controls

**Type:** NO_INTERVENTION

#### Arm Group 3

**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

**Intervention Names:**

- Behavioral: Health reccommendations

**Label:** GIM cases

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- GIM cases

**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

**Name:** Health reccommendations

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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)

**Measure:** Risk of developing Gastric Cancer based on medical records

**Time Frame:** At the recruitment stage

**Description:** AI driven H. pylori Eradication Therapy Recommendation

**Measure:** H. pylori Eradication Therapy Recommendation

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

**Description:** 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

**Measure:** GIM risk score assessment using imaging modalities

**Time Frame:** At the recruitment stage

### Eligibility Module

**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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** amiralles@incliva.es

**Name:** Ana Miralles Marco, PhD

**Phone:** +34 689567412

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Valencia

**Country:** Spain

**Facility:** Hospital Clínico Universitario de Valencia

**Zip:** 46010

#### Overall Officials

**Official 1:**

**Affiliation:** Fundación para la Investigación del Hospital Clínico de Valencia

**Name:** Tania Fleitas, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** Website

**URL:** https://www.aidaeuproject.org/

## Document Section

### Large Document Module

#### Large Docs

- Date: 2023-02-07

- Filename: ICF_000.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 499898

- Type Abbrev: ICF

- Upload Date: 2024-05-07T10:27

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000013272

- Term: Stomach Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16064

- Name: Stomach Neoplasms

- Relevance: HIGH

- As Found: Gastric Cancer

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16062

- Name: Stomach Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5486

- Name: Stomach Cancer

- Relevance: HIGH

- As Found: Gastric Cancer

### Condition Browse Module - Meshes

- ID: D000013274

- Term: Stomach Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
