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AI-Based Risk Prediction Model for Upper Digestive Tract Cancer

25 de maio de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

10000

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Jyh-Ming Liou, MD, PhD
Número de telefone: +886972651883
E-mail: jyhmingliou@gmail.com

Estude backup de contato

Nome: Tzu-Chan Hong, MD, PhD
Número de telefone: 238061 +886-2-2322-0322
E-mail: edisonhong77@gmail.com

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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:

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Number of participants with upper digestive tract cancer confirmed by histopathological examination Prazo: "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"

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Recurrent colon polyps Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

National Taiwan University Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

18 de maio de 2026

Conclusão Primária (Estimado)

18 de maio de 2030

Conclusão do estudo (Estimado)

18 de maio de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

17 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ