AI-Based Risk Prediction Model for Upper Digestive Tract Cancer
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.
Descripción general del estudio
Estado
Descripción detallada
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 estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jyh-Ming Liou, MD, PhD
- Número de teléfono: +886972651883
- Correo electrónico: jyhmingliou@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Tzu-Chan Hong, MD, PhD
- Número de teléfono: 238061 +886-2-2322-0322
- Correo electrónico: edisonhong77@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
- 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.
Descripción
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:
-
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of participants with upper digestive tract cancer confirmed by histopathological examination
Periodo de tiempo: "From enrollment to the end of follow-up at 10 years"
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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.
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"From enrollment to the end of follow-up at 10 years"
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Recurrent colon polyps
Periodo de tiempo: From enrollment to the end of follow-up at 10 years
|
From enrollment to the end of follow-up at 10 years
|
|
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Number of participants with progression of gastric premalignant lesions assessed by OLGA, OLGIM, and EGGIM staging systems
Periodo de tiempo: 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.
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From enrollment to the end of follow-up at 10 years
|
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Number of participants with non-upper digestive tract malignancies confirmed by histopathological examination
Periodo de tiempo: 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
Periodo de tiempo: 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.
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From enrollment to the end of follow-up at 10 years
|
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Number of participants with symptom or endoscopic improvement after medication treatment in gastroesophageal reflux disease and dyspepsia populations
Periodo de tiempo: 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
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From enrollment to the end of follow-up at 10 years
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Estómago
- Neoplasias de Cabeza y Cuello
- Enfermedades esofágicas
- Gastroenteritis
- Gastritis
- Neoplasias de Estómago
- Neoplasias Esofágicas
- Gastritis Atrófica
Otros números de identificación del estudio
- 202105028RINC
Información sobre medicamentos y dispositivos, documentos del estudio
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