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AI-Based Risk Prediction Model for Upper Digestive Tract Cancer

25. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Antatt)

10000

Kontakter og plasseringer

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Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

  • 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.

Beskrivelse

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:

-

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants with upper digestive tract cancer confirmed by histopathological examination
Tidsramme: "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"

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Recurrent colon polyps
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

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Sponsor

National Taiwan University Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

18. mai 2026

Primær fullføring (Antatt)

18. mai 2030

Studiet fullført (Antatt)

18. mai 2030

Datoer for studieregistrering

Først innsendt

17. mai 2026

Først innsendt som oppfylte QC-kriteriene

17. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 202105028RINC

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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