AI-Based Risk Prediction Model for Upper Digestive Tract Cancer (NCT07605312) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
AI-Based Risk Prediction Model for Upper Digestive Tract Cancer
10,000 participantsStarted 2026-05-18
Plain-language summary
Upper digestive tract cancers are often preceded by pre-malignant lesions, but there is limited evidence regarding optimal risk prediction models and screening strategies for disease progression and cancer development. This prospective multicenter cohort study aims to establish a longitudinal database integrating clinical information, endoscopic findings, pathology, genetics, epigenetics, and gastrointestinal microbiota data from subjects undergoing upper digestive tract endoscopy.
The study will develop explainable artificial intelligence (AI)-based risk prediction models to identify factors associated with disease progression, treatment response, and cancer development. Participants will be followed longitudinally to evaluate changes in lesion severity and clinical outcomes.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients undergoing upper gastrointestinal endoscopy.
* Patients with at least one of the following conditions or indications:
* Previous or current Helicobacter pylori infection (confirmed by serology, histopathology, urea breath test, rapid urease test, or stool antigen test);
* Dyspeptic symptoms;
* Gastroesophageal reflux disease;
* History of oral, oropharyngeal, or hypopharyngeal squamous cell carcinoma;
* Barrett's esophagus;
* Gastric premalignant lesions (intestinal metaplasia or atrophic gastritis);
* Gastric subepithelial lesions.
Exclusion Criteria:
\-
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on predicting risk for upper digestive tract cancers like gastric and esophageal cancer — given my specific diagnosis of something like atrophic gastritis or intestinal metaplasia, would participating in an AI risk prediction study actually change how my condition is monitored or treated, or is it more about contributing data?
2Since this trial is listed as 'not yet recruiting,' how long might it be before it actually opens, and is there a reason to wait for it rather than pursuing standard surveillance or treatment options right now?
3The trial seems to be measuring how many participants are confirmed with cancer through tissue biopsy — does that mean I would need to undergo additional endoscopies or biopsies as part of this study, and how does that compare to what I'd already need for my regular care?
4This study is Phase NA, which suggests it's more of an observational or diagnostic tool study rather than a treatment trial — can you help me understand whether this is about predicting my risk or actually doing anything to reduce it?
5Are there standard clinical guidelines already in place for monitoring conditions like mine, such as gastric intestinal metaplasia or dysplasia, and would joining this AI prediction study complement those or potentially delay me getting proven care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with upper digestive tract cancer confirmed by histopathological examination
Timeframe: "From enrollment to the end of follow-up at 10 years"