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Development of a Non-Invasive Method for Assessing the Risk of H. pylori-Negative Gastric Cancer to Optimize Gastric Cancer Screening Programs

Establishment of a Non-Invasive Risk Stratification Approach for Helicobacter pylori-Negative Gastric Cancer Aimed at Optimizing Population-Based Gastric Cancer Screening Programs - Artificial Intelligence-Based Risk Assessment of H. pylori-Negative Gastric Cancer: Development and Validation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000057846
Enrollment
3000
Registered
2025-06-01
Start date
2025-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

None listed

Sponsors

International University of Health and Welfare Ichikawa Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Accuracy, precision, recall, AUC of the ROC curve, and RMSE of the constructed AI.

Secondary

MeasureTime frame
The background and lesion characteristics of H. pylori-naive gastric cancer cases and H. pylori-naive non-gastric cancer cases.

Countries

Japan

Contacts

Public ContactFumiaki Ishibashi

International University of Health and Welfare Ichikawa Hospital Department of Gastroenterology

ishibashi-gast@iuhw.ac.jp047-375-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026