This multicenter retrospective and prospective real-world observational study will evaluate the relationship of Helicobacter pylori (H. pylori) infection status, intragastric distribution, and pathological features with gastric cancer biological behavior and long-term prognosis in patients with early gastric cancer or related gastric neoplastic lesions undergoing endoscopic submucosal dissection (ESD).
H. pylori infection is an important risk factor for gastric cancer. In clinical practice, H. pylori status can be assessed by several methods, including the 13C-urea breath test, serum H. pylori antibody testing, and pathological assessment of gastric tissue. These methods may not always provide the same result because they reflect different aspects of infection, including current active infection, previous exposure, prior eradication status, and local tissue-based detection.
The study will include approximately 1500 participants from participating medical centers. About 1000 participants will be retrospectively identified from existing clinical, endoscopic, pathological, H. pylori testing, and follow-up records, and about 500 additional participants will be prospectively enrolled.
The study will evaluate H. pylori infection status, prior eradication status, discordant testing patterns, tissue-based and intragastric H. pylori distribution, background mucosal changes, and pathological features of early gastric cancer or related gastric neoplastic lesions. These features will be analyzed in relation to different gastric cancer subtypes and biological behavior.
Follow-up information will be used to evaluate whether the integrated analysis of H. pylori infection status and pathological features can predict clinical outcomes at 1, 2, and 3 years after ESD and during long-term follow-up, including local recurrence, metachronous gastric cancer, synchronous or multifocal early gastric cancer detected within 1 year, additional surgical treatment, survival, and other clinically meaningful outcomes.
Adults aged 18 to 80 years
Retrospectively identified or prospectively enrolled patients with early gastric cancer, high-grade intraepithelial neoplasia, or other gastric neoplastic lesions treated with or scheduled for endoscopic submucosal dissection according to standard clinical indications at participating medical centers
Availability or planned availability of sufficient Helicobacter pylori assessment data for study classification, including 13C-urea breath test, serum Helicobacter pylori IgG antibody testing, pathological assessment of gastric tissue, prior H. pylori infection history, prior eradication history, eradication confirmation, or follow-up H. pylori testing results when available
Availability or planned availability of gastric tissue pathological assessment from routine biopsy specimens and/or endoscopic submucosal dissection specimens for evaluation of tissue-based H. pylori detection, background mucosal changes, lesion pathological characteristics, and ESD-related pathological findings
Patients whose final diagnosis does not meet the study population definition, including those without early gastric cancer, high-grade intraepithelial neoplasia, or other eligible gastric neoplastic lesions
Insufficient clinical, H. pylori testing, endoscopic, pathological, or follow-up information to classify H. pylori infection or eradication status or to evaluate the main study outcomes
Lack of adequate pathological material or pathological information for assessment of gastric lesion characteristics, tissue-based H. pylori detection, or background mucosal changes
Previous gastrectomy or major gastric surgery that substantially alters gastric anatomy and prevents reliable assessment of lesion location, intragastric distribution, or background mucosal status
Adults aged 18 to 80 years with early gastric cancer, high-grade intraepithelial neoplasia, or other gastric neoplastic lesions treated with or scheduled for endoscopic submucosal dissection at participating medical centers. The study will include approximately 1000 retrospectively identified participants with available clinical, endoscopic, pathological, H. pylori testing, and follow-up records, and approximately 500 prospectively enrolled participants. H. pylori infection and eradication status, tissue-based and intragastric H. pylori distribution, pathological features, gastric cancer subtype, biological behavior, ESD curability, and outcomes at 1, 2, and 3 years after ESD and during long-term follow-up will be evaluated.
Cohort
Other
13C-Urea Breath Test
Diagnostic testThe 13C-urea breath test is performed before endoscopic submucosal dissection as part of routine clinical evaluation to assess current active Helicobacter pylori infection. The result will be compared with serum Helicobacter pylori antibody testing and pathological assessment to evaluate diagnostic concordance. This test is not assigned as an experimental intervention by the study protocol.
Serum Helicobacter pylori Antibody Testing
Diagnostic testSerum Helicobacter pylori antibody testing is performed before endoscopic submucosal dissection as part of routine clinical evaluation to assess previous or current exposure to H. pylori. The result will be compared with the 13C-urea breath test and pathological assessment to evaluate diagnostic concordance and discordant H. pylori testing patterns.
Pathological Assessment of Gastric Tissue
Diagnostic testPathological assessment of gastric biopsy specimens and/or endoscopic submucosal dissection specimens will be performed as part of routine clinical care. Tissue-based findings will be used to evaluate H. pylori detection in tumor tissue, lesion-adjacent mucosa, and non-lesion background mucosa when available. Background mucosal changes such as chronic inflammation, active inflammation, atrophy, intestinal metaplasia, and other pathology-reported findings will be recorded. Gastric cancer pathological features, including histology, differentiation, invasion depth, lymphovascular invasion, and margin status, will also be assessed.
Endoscopic Submucosal Dissection
Procedure/SurgeryEndoscopic submucosal dissection is performed as standard clinical treatment for eligible early gastric cancer or related gastric neoplastic lesions. The procedure is not assigned by the study protocol. ESD-related procedural data, resection quality, postoperative outcomes, pathological findings, recurrence, metachronous gastric cancer, and long-term prognosis will be collected for observational analysis.
Concordance Rate Among Three H. pylori Testing Modalities in Post-Eradication Gastric Cancer
The concordance rate among three H. pylori testing modalities will be reported in participants with post-eradication gastric cancer. The three testing modalities include 13C-urea breath test, serum H. pylori antibody testing, and pathological assessment of gastric tissue. Each test result will be classified as positive or negative according to the corresponding clinical laboratory or pathology report. Concordance is defined as all three testing modalities yielding the same binary result, either all positive or all negative. The unit of measure is the percentage of participants with concordant results among participants with available results from all three testing modalities.
Positive Detection Rate of Serum H. pylori Antibody Testing in Post-Eradication Gastric Cancer
The positive detection rate of serum H. pylori antibody testing will be reported in participants with post-eradication gastric cancer. The unit of measure is the percentage of participants with a positive or weakly positive serum H. pylori antibody result among participants with available test results.
Positive Detection Rate of Pathological H. pylori Assessment in Post-Eradication Gastric Cancer
The positive detection rate of pathological H. pylori assessment will be reported in participants with post-eradication gastric cancer. The unit of measure is the percentage of participants with H. pylori detected by pathological assessment of gastric biopsy or endoscopic submucosal dissection specimens among participants with available pathological results.
Discordance Rate Among Three H. pylori Testing Modalities in Post-Eradication Gastric Cancer
The discordance rate among three H. pylori testing modalities will be reported in participants with post-eradication gastric cancer. Discordance is defined as inconsistent binary results among 13C-urea breath test, serum H. pylori antibody testing, and pathological assessment of gastric tissue. The unit of measure is the percentage of participants with discordant results among participants with available results from all three testing modalities.
Kappa Coefficient for Agreement Among Three H. pylori Testing Modalities
The kappa coefficient for agreement among 13C-urea breath test, serum H. pylori antibody testing, and pathological assessment of gastric tissue will be calculated when sufficient data are available.
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