Health TrialsbyHealthPanel

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

ConditionsGastric CancerCancer PreventionHelicobacter Pylori InfectionArtificial Intelligence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación para la Investigación del Hospital Clínico de Valencia

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

450 Participants
are divided into 3 treatment groups
Group A: Healthy controlsNo intervention 0 interventions
Group B: Gastric cancer controlsNo intervention 0 interventions
Group C: GIM casesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
At the recruitment stage
2

H. pylori Eradication Therapy Recommendation

AI driven H. pylori Eradication Therapy Recommendation

Time frame
From 30 days after the H.Pylori positive test result to one year after the first recommendation
3

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

Time frame
At the recruitment stage

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación para la Investigación del Hospital Clínico de Valencia

Lead sponsor

Source ClinicalTrials.gov
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