AI-Based Risk Prediction Model for Upper Digestive Tract Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients undergoing upper gastrointestinal endoscopy.

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;

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Number of participants with upper digestive tract cancer confirmed by histopathological examination

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.

Time frame
"From enrollment to the end of follow-up at 10 years"

Secondary outcomes

1

Number of participants with progression of gastric premalignant lesions assessed by OLGA, OLGIM, and EGGIM staging systems

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.

Time frame
From enrollment to the end of follow-up at 10 years
2

Recurrent colon polyps

Time frame
From enrollment to the end of follow-up at 10 years
3

Number of participants with non-upper digestive tract malignancies confirmed by histopathological examination

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.

Time frame
From enrollment to the end of follow-up at 10 years
4

Number of participants with newly diagnosed metabolic and cardiovascular diseases

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.

Time frame
From enrollment to the end of follow-up at 10 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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