Actively Recruiting
Interventional Study Providing Personalised Health Recommendations Using an AI-Guided App for Gastric Cancer Prevention (AIDA)
Led by Fundación para la Investigación del Hospital Clínico de Valencia · Updated on 2025-02-27
450
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an AI-powered tool called AIDA designed to assist clinicians in diagnosing precancerous inflammation, suggesting personalized treatments and follow-up care, and providing health monitoring recommendations to help prevent gastric cancer. This prospective clinical study aims to implement and validate this multidisciplinary assistant through two phases: risk stratification with personalized recommendations, and mechanistic model development with testing. Participants will be recruited from digestive medicine and endoscopy departments. They will undergo gastroscopy as part of their usual clinical care, during which samples will be collected for pathological and molecular analysis. The study groups include healthy controls, gastric cancer patients, and individuals with gastric intestinal metaplasia (GIM) or Helicobacter pylori infection. Patients receive personalized health recommendations based on their risk group, which are communicated to their treating physicians to align with clinical guidelines. During the study, researchers will assess participants' risk of developing gastric cancer using medical records and imaging at recruitment. Recommendations for H. pylori eradication therapy will be provided starting 30 days after a positive test and followed for up to one year. The study involves no additional risks beyond usual care. Participant involvement includes routine gastroscopy, sample collection, and monitoring through medical records and health indicators assessed by the AI tool.
CONDITIONS
Brief Title
Personalised Health Recommendations to the General Population Through an Integrated AI Guided
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects 18 years or older with gastric intestinal metaplasia or current or previous Helicobacter pylori infection who have a gastroscopy indicated as part of their clinical care
- Signed informed consent form to participate in the study
You will not qualify if you...
- Patients undergoing endoscopy for other illnesses like oesophageal varices or for therapeutic procedures such as dilation, feeding tube placement, or endoscopic resection
- Subjects with gastric diseases other than gastric intestinal metaplasia or gastric cancer
- Patients who received antimicrobials in the 4 weeks before endoscopy
- Patients who used proton pump inhibitors or bismuth-based treatments at least 2 weeks before endoscopy
- Subjects lacking clinical data such as H. pylori status, eradication treatment, sex, age, smoking history, or family history of gastric cancer
- Subjects unable to understand the study or unable to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 30 days after the H. pylori positive test result to one year after the first recommendation
Participants receive personalised health recommendations based on their risk group using an AI-guided app. These recommendations are aligned with clinical care practice guidelines and sent to the participant's treating physician.
Visits scheduled according to clinical care and monitoring needs
Duration - Up to recruitment stage and ongoing as per clinical care
Participants are monitored for risk of developing gastric cancer and for assessment of gastric intestinal metaplasia risk using imaging modalities, as part of ongoing clinical care.
Sample collection during gastroscopy as part of routine clinical care; additional assessments may occur depending on clinical indications
Trial Site Locations
Total: 1 location
1
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
A
Ana Miralles Marco, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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