AI-Based Risk Prediction Model for Upper Digestive Tract Cancer
Development of Artificial Intelligence Risk Prediction Model for Upper Digestive Tract Cancer Using High Resolution Endoscopic Image, Digital Pathology, Genetics, and Oro-gastro-intestinal Microbiota.
1 other identifier
observational
10,000
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2026
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2026
CompletedStudy Start
First participant enrolled
May 18, 2026
CompletedFirst Posted
Study publicly available on registry
May 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 18, 2030
May 22, 2026
May 1, 2026
4 years
May 17, 2026
May 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Upper digestive tract cancer development
"From enrollment to the end of follow-up at 10 years"
Secondary Outcomes (5)
Progression in pre-malignant lesions
From enrollment to the end of follow-up at 10 years
Recurrent colon polyps
From enrollment to the end of follow-up at 10 years
Other cancer development
From enrollment to the end of follow-up at 10 years
Metabolic and cardiovascular disease
From enrollment to the end of follow-up at 10 years
Response to medication in gastro-esophageal reflux and dyspepsia population
From enrollment to the end of follow-up at 10 years
Eligibility Criteria
* Patients with a history of surgery involving the esophagus, stomach, or duodenum. * Patients with gastric deformity secondary to severe gastric inflammation. * Patients unable to undergo regular follow-up upper gastrointestinal endoscopy every 1-3 years. * Patients with severe comorbidities that preclude follow-up upper gastrointestinal endoscopy or with an estimated life expectancy of less than 10 years.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Upper GI Endoscopic biopsy or resected samples Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2026
First Posted
May 22, 2026
Study Start
May 18, 2026
Primary Completion (Estimated)
May 18, 2030
Study Completion (Estimated)
May 18, 2030
Last Updated
May 22, 2026
Record last verified: 2026-05