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NCT07724496

Overview

NCT ID: NCT07724496
Lead Sponsor: Chinese PLA General HospitalOTHER
Official Title: A Multicenter Retrospective and Prospective Real-World Observational Study of Helicobacter Pylori Infection Status and Pathological Features of Early Gastric Cancer for Predicting Biological Behavior and Prognosis Across Gastric Cancer Subtypes
Brief 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.

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 24, 2026Actual
Start Date: Jan 1, 2024Actual
Primary Completion Date: Dec 30, 2031Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 1,500Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: He Zhou, PhDContact
zh505593673@163.com+86-13029650138

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Participant Group/Arms

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Participants with early gastric cancer or related gastric neoplastic lesions who have evidence of current active Helicobacter pylori infection before endoscopic submucosal dissection and no documented history of prior H. pylori eradication therapy. Current active infection is primarily defined by a positive 13C-urea breath test and/or positive tissue-based pathological detection of H. pylori before or at the time of ESD. Serum H. pylori antibody status, pathological features, tissue-based H. pylori distribution, and long-term outcomes will be recorded and analyzed.

Diagnostic Test: 13C-Urea Breath Test

Diagnostic Test: Serum Helicobacter pylori Antibody Testing

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Diagnostic Test: 13C-Urea Breath Test

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Diagnostic Test: 13C-Urea Breath Test

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Diagnostic Test: 13C-Urea Breath Test