Clinical trial · Observational
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atrophic Gastritis | — | UNRESOLVED | — |
| Dysplasia Stomach | — | UNRESOLVED | — |
| Esophageal Cancer (EsC) | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.85 |
| Gastric Cancer (GC) | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Intestinal Metaplasia | — | UNRESOLVED | — |
| Premalignant Lesion | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of participants with upper digestive tract cancer confirmed by histopathological examination
- timeFrame
- "From enrollment to the end of follow-up at 10 years"
- description
- Upper digestive tract cancer development will be defined as newly diagnosed upper digestive tract malignancy during follow-up, including esophageal cancer and gastric cancer. Diagnosis will be confirmed by histopathological examination of biopsy or resection specimens.
Secondary outcomes (5)
- measure
- Number of participants with progression of gastric premalignant lesions assessed by OLGA, OLGIM, and EGGIM staging systems
- timeFrame
- From enrollment to the end of follow-up at 10 years
- description
- Progression of premalignant lesions will be defined as worsening of gastric atrophy and intestinal metaplasia during follow-up based on histological and endoscopic assessment. Histological progression will be evaluated using changes in OLGA and OLGIM stages, while endoscopic progression will be assessed using EGGIM scores. Progression is defined as an increase in stage or score compared with baseline evaluation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
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: \-
References
Publications (0)
Data not yet available