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AI-Based Risk Prediction Model for Upper Digestive Tract Cancer

25 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

10000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

  • 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.

Beschrijving

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:

-

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of participants with upper digestive tract cancer confirmed by histopathological examination
Tijdsspanne: "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"

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Recurrent colon polyps
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Taiwan University Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

18 mei 2026

Primaire voltooiing (Geschat)

18 mei 2030

Studie voltooiing (Geschat)

18 mei 2030

Studieregistratiedata

Eerst ingediend

17 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 mei 2026

Eerst geplaatst (Werkelijk)

22 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

25 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 202105028RINC

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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