Helicobacter Pylori Infection Status and Pathological Features for Predicting Gastric Cancer Biological Behavior and Prognosis: A Real-World Observational 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.

Conditions

• Helicobacter Pylori
• Early Gastric Cancer

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

PROCEDURE

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.

Sponsors & Collaborators

• Chinese PLA General Hospital

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2031-12-30

Completion

2031-12-30

Countries

• China

Study Locations