AI-Based Risk Prediction Model for Upper Digestive Tract Cancer

May 25, 2026 updated by: National Taiwan University Hospital

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Objectives:

There is no solid evidence about the risk prediction model and screening duration for upper digestive tract pre-malignant lesions and its progression. There is also no longitudinal study combining multi-omic approach, endoscopic and pathologic images and the association with disease development. Hence we design a prospective cohort targeting upper digestive tract disease progression and cancer development, with standardized clinical data collection, quality control and explainable AI (artificial intellegence) model for better reliability of risk prediction model.

Aims:

We aim to develop risk prediction model for the progression of upper digestive tract disease and cancer development.

Methods:

The study is disigned as a multi-center prospective cohort, targeting subjects undergoing upper digestive tract endoscopy. The development of AI risk prediction models will combine endoscopic pre-malignant lesion, pathology, genetics, epigenetics, oro-gastro-intestinal microbiota, and follow-up longitudinally with change in lesion severity, medication response, cancer development.

Outcome measurement:

Primary endpoints: upper digestive tract cancer development. Secondary endpoints: progression in pre-malignant lesions, recurrent colon polyps, other cancer developement, metabolic and cardiovascular disease, response to medication in gastro-esophageal reflux and dyspepsia population.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

  • 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.

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with upper digestive tract cancer confirmed by histopathological examination
Time Frame: "From enrollment to the end of follow-up at 10 years"
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.
"From enrollment to the end of follow-up at 10 years"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent colon polyps
Time Frame: From enrollment to the end of follow-up at 10 years
From enrollment to the end of follow-up at 10 years
Number of participants with progression of gastric premalignant lesions assessed by OLGA, OLGIM, and EGGIM staging systems
Time Frame: From enrollment to the end of follow-up at 10 years
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.
From enrollment to the end of follow-up at 10 years
Number of participants with non-upper digestive tract malignancies confirmed by histopathological examination
Time Frame: From enrollment to the end of follow-up at 10 years
Other cancer development will be defined as newly diagnosed malignancies other than upper digestive tract cancers during follow-up, including but not limited to colorectal cancer, hepatobiliary cancer, pancreatic cancer, lung cancer, breast cancer, prostate cancer, and hematologic malignancies. Diagnosis will be confirmed by histopathological examination, imaging findings, or cancer registry records.
From enrollment to the end of follow-up at 10 years
Number of participants with newly diagnosed metabolic and cardiovascular diseases
Time Frame: From enrollment to the end of follow-up at 10 years
Metabolic and cardiovascular disease development will be defined as newly diagnosed metabolic or cardiovascular conditions during follow-up, including diabetes mellitus, hypertension, dyslipidemia, coronary artery disease, cerebrovascular disease, heart failure, and peripheral arterial disease. Diagnoses will be confirmed based on medical records and clinical assessments.
From enrollment to the end of follow-up at 10 years
Number of participants with symptom or endoscopic improvement after medication treatment in gastroesophageal reflux disease and dyspepsia populations
Time Frame: From enrollment to the end of follow-up at 10 years
Treatment response will be defined as improvement of reflux and dyspeptic symptoms after medical therapy during follow-up. Symptom response will be assessed based on patient-reported symptom improvement and medical records. Endoscopic response will be assessed endoscopically
From enrollment to the end of follow-up at 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 18, 2026

Primary Completion (Estimated)

May 18, 2030

Study Completion (Estimated)

May 18, 2030

Study Registration Dates

First Submitted

May 17, 2026

First Submitted That Met QC Criteria

May 17, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202105028RINC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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