Recruiting
Observational
Helicobacter Pylori Infection Status and Pathological Features for Predicting Gastric Cancer Biological Behavior and Prognosis: A Real-World Observational Study
Condition(s) studied
Helicobacter PyloriEarly Gastric Cancer
Investigational drug(s) / intervention(s)
13C-Urea Breath TestSerum Helicobacter pylori Antibody TestingPathological Assessment of Gastric TissueEndoscopic Submucosal Dissection
13C-Urea Breath Test: The 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: Serum 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: Pathological 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: Endoscopic 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.
Study summary
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.
Eligibility
Inclusion Criteria:
* 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
* Availability or planned availability of key clinical, endoscopic, and pathological information required to evaluate gastric cancer subtype, biological behavior, and curability after ESD, including lesion location, histological subtype, differentiation, depth of invasion, lymphovascular invasion, margin status, curative resection status, and additional treatment information when available
* Availability of follow-up data for retrospectively included participants, or willingness and ability to participate in follow-up evaluations for prospectively enrolled participants, including endoscopic follow-up at approximately 1, 2, and 3 years after ESD and longer-term follow-up when available
* Adequate cardiac, hepatic, renal, and pulmonary function to tolerate endoscopic treatment and routine follow-up for prospectively enrolled participants scheduled for ESD
* Ability to provide written informed consent for prospectively enrolled participants, or availability of ethics-approved retrospective clinical data for retrospectively included participants
Exclusion Criteria:
* 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
* For prospectively enrolled participants scheduled for ESD, severe comorbid conditions, such as uncontrolled cardiovascular or cerebrovascular disease, severe coagulopathy, or very poor general condition, that make endoscopic submucosal dissection unsafe
* For prospectively enrolled participants scheduled for ESD, anticoagulant or antiplatelet therapy that cannot be safely interrupted or managed during the perioperative period, or active bleeding tendency judged to significantly increase procedural risk
* Pregnancy or breastfeeding for prospectively enrolled participants
* Inability or unwillingness to comply with study procedures or follow-up requirements for prospectively enrolled participants
* Any other condition judged by the investigators to make the participant unsuitable for the study
Primary outcome measure(s)
- Concordance Rate Among Three H. pylori Testing Modalities in Post-Eradication Gastric Cancer — From baseline H. pylori testing to pathological assessment within 2 weeks after endoscopic submucosal dissection
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.
Trial sites (3)
| Facility | City | Region | Status |
|---|
| The Eighth Medical Center of Chinese PLA General Hospital |
Beijing |
Beijing Municipality |
Recruiting |
| First Medical Center of Chinese PLA General Hospital |
Beijing |
Beijing Municipality |
Recruiting |
| Department of Gastroenterology, Rocket Force Characteristic Medical Center |
Beijing |
Beijing Municipality |
Recruiting |
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