UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057846 |
|---|---|
| Receipt number | R000066120 |
| Scientific Title | Establishment of a Non-Invasive Risk Stratification Approach for Helicobacter pylori-Negative Gastric Cancer Aimed at Optimizing Population-Based Gastric Cancer Screening Programs |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/05/13 06:18:16 |
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Basic information
Public title
Development of a Non-Invasive Method for Assessing the Risk of H. pylori-Negative Gastric Cancer to Optimize Gastric Cancer Screening Programs
Acronym
Development of Artificial Intelligence for Risk Assessment of H. pylori-Negative Gastric Cancer
Scientific Title
Establishment of a Non-Invasive Risk Stratification Approach for Helicobacter pylori-Negative Gastric Cancer Aimed at Optimizing Population-Based Gastric Cancer Screening Programs
Scientific Title:Acronym
Artificial Intelligence-Based Risk Assessment of H. pylori-Negative Gastric Cancer: Development and Validation
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Gastric cancer screening using endoscopy, implemented as a population-based measure to facilitate early detection and reduce mortality, may become less effective in the future as the prevalence of Helicobacter pylori (H. pylori) infection continues to decline. Although rare, gastric cancer can still occur in individuals uninfected with H. pylori, making risk prediction for H. pylori-negative gastric cancer an important public health concern.
Recent efforts have aimed to develop artificial intelligence (AI) models that predict the risk of gastric cancer using variables such as age, comorbidities, endoscopic findings, and histopathological data among individuals who have undergone upper gastrointestinal endoscopy. However, all of these approaches rely on endoscopic examination for risk stratification.
Considering future social implementation, there is a need to establish risk assessment methods that do not depend on endoscopic data. This study aims to develop an AI-based model capable of stratifying gastric cancer risk in H. pylori-negative individuals using non-endoscopic variables, such as dietary habits, lifestyle factors, and underlying health conditions, by conducting a cross-sectional survey of patients with and without gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy, precision, recall, AUC of the ROC curve, and RMSE of the constructed AI.
Key secondary outcomes
The background and lesion characteristics of H. pylori-naive gastric cancer cases and H. pylori-naive non-gastric cancer cases.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. H. pylori-Negative Gastric Cancer Cases
All patients diagnosed and treated for Helicobacter pylori (H. pylori)-negative gastric cancer during the study period will be included. The target population also includes gastric cancers located at the esophagogastric junction classified as Siewert type II or III, as well as gastric cancers occurring in patients with hereditary diffuse gastric cancer (HDGC), familial adenomatous polyposis (FAP), and other hereditary gastrointestinal cancer syndromes.
H. pylori-negative status is defined as meeting all of the following criteria:
i) At least one negative result in H. pylori diagnostic tests (e.g., serum anti-H. pylori IgG antibody, urea breath test, or direct microscopic examination of gastric mucosal biopsy specimens),
ii) No endoscopic evidence of gastric mucosal atrophy,
iii) No history of H. pylori eradication therapy.
2. H. pylori-Negative Non-Gastric Cancer Cases
Patients confirmed to be H. pylori-negative and without evidence of gastric cancer on upper gastrointestinal endoscopy performed under the national health insurance system are eligible.
To confirm H. pylori-negative status endoscopically, the following criteria are used:
i) Presence of regular arrangement of collecting venules (RAC),
ii) Presence of foveolar-hyperplastic red streaks (linear red streaks), hematin adherence, or fundic gland polyps, which are indicative of an uninfected gastric mucosa,
iii) Absence of endoscopic atrophy, and
iv) Absence of active H. pylori infection findings such as diffuse redness, increased mucus secretion, or thickened folds of the greater curvature of the gastric body.
A comprehensive judgment is made based on these findings to confirm H. pylori-negative status.
Key exclusion criteria
Patients with an undetermined final pathological diagnosis will be excluded. In addition, H. pylori-negative gastric tumors classified as foveolar-type gastric adenomas -such as raspberry-type and flat-type lesions- will be excluded, as they are categorized as adenomas under the 5th edition of the WHO Classification of Tumors.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Fumiaki |
| Middle name | |
| Last name | Ishibashi |
Organization
International University of Health and Welfare Ichikawa Hospital
Division name
Department of Gastroenterology
Zip code
272-0827
Address
6-1-14, Konodai, Ichikawa-shi, Chiba
TEL
047-375-1111
ishibashi-gast@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Fumiaki |
| Middle name | |
| Last name | Ishibashi |
Organization
International University of Health and Welfare Ichikawa Hospital
Division name
Department of Gastroenterology
Zip code
272-0827
Address
6-1-14, Konodai, Ichikawa-shi, Chiba
TEL
047-375-1111
Homepage URL
ishibashi-gast@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Ichikawa Hospital
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
4-3, Kozunomori, Narita-shi, Chiba
Tel
0476-20-7708
rinri_md@iuhw.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Basic Information:
Name of a participating institution, participant's name, date of birth, age, sex, place of birth, height and weight at the time of the most recent endoscopic examination, smoking and alcohol consumption history at the time of gastric cancer diagnosis, family history of gastric cancer within second-degree relatives, personal history of gastric cancer, and history of other malignancies.
Medical Information:
Presence of comorbidities at the time of gastric cancer diagnosis (including diabetes mellitus, hypertension, coronary artery disease, chronic obstructive pulmonary disease, chronic kidney disease, osteoporosis) and history of medication use.
Dietary Habits:
Data collected using a semi-quantitative food frequency questionnaire, covering the intake frequency and content of staple and side dishes (dairy products, legumes, seafood, eggs, meat, oils, vegetables, mushrooms, seaweed), fruits, snacks, and beverages for breakfast, lunch, and dinner.
Data Collection Schedule:
Data will be collected over a one-year period following approval by the ethics committee.
Management information
Registered date
| 2025 | Year | 05 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066120
