Gastric Cancer (GC)NCT07605312
AI-Based Risk Prediction Model for Upper Digestive Tract Cancer
An observational study of Gastric Cancer (GC) and Premalignant Lesion, run by National Taiwan University Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer (GC), Premalignant Lesion, Gastric Intestinal Metaplasia
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 18 May 2026to 18 May 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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;
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- Barrett's esophagus;
- Gastric premalignant lesions (intestinal metaplasia or atrophic gastritis);
- Gastric subepithelial lesions.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Gastric Cancer (GC), Premalignant Lesion, Gastric Intestinal Metaplasia, Atrophic Gastritis, Dysplasia Stomach, Esophageal Cancer (EsC)
- Medical subject headings
- Stomach Neoplasms, Gastritis, Atrophic, Esophageal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "From enrollment to the end of follow-up at 10 years"
Secondary outcomes (5)
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.
Measured: From enrollment to the end of follow-up at 10 years
Recurrent colon polyps
Measured: From enrollment to the end of follow-up at 10 years
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.
Measured: From enrollment to the end of follow-up at 10 years
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.
Measured: 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
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
Measured: From enrollment to the end of follow-up at 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start18 May 2026 (estimated)
- Primary completion18 May 2030 (estimated)
- Study completion18 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605312
- Sponsor's protocol ID
- 202105028RINC
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07605312
- Acronym / sponsor ID
- 202105028RINC
- Conditions
- Gastric Cancer (GC), Premalignant Lesion, Gastric Intestinal Metaplasia, Atrophic Gastritis, Dysplasia Stomach, Esophageal Cancer (EsC)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 18 May 2026 (estimated)
- Primary completion
- 18 May 2030 (estimated)
- Study completion
- 18 May 2030 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (9 listed)
- Patients undergoing upper gastrointestinal endoscopy.
- Patients with at least one of the following conditions or indications:
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with upper digestive tract cancer confirmed by histopathological examination
Time frame: "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.
5 secondary outcomes
Number of participants with progression of gastric premalignant lesions assessed by OLGA, OLGIM, and EGGIM staging systems
Time frame: From enrollment to the end of follow-up at 10 years
Recurrent colon polyps
Time frame: From enrollment to the end of follow-up at 10 years
Number of participants with non-upper digestive tract malignancies confirmed by histopathological examination
Time frame: From enrollment to the end of follow-up at 10 years
Number of participants with newly diagnosed metabolic and cardiovascular diseases
Time frame: 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
Time frame: From enrollment to the end of follow-up at 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer (GC) and Premalignant Lesion, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jyh-Ming Liou, MD, PhD (+886972651883, jyhmingliou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with upper digestive tract cancer confirmed by histopathological examination (time frame: "From enrollment to the end of follow-up at 10 years"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.