NCT07724496Recruiting
Helicobacter Pylori Infection Status and Pathological Features for Predicting Gastric Cancer Biological Behavior and Prognosis: A Real-World Observational Study
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
Source: ClinicalTrials.gov · Last updated 24 Jul 2026
Brief summary (registry, in English)
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 (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1500 (estimated)
- First submitted
- 16 Jun 2026
- Start date
- 1 Jan 2024
- Primary completion date
- 30 Dec 2031
- Lead sponsor
- Chinese PLA General Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07724496
What you commit to
- Study type: Observational
- Planned participants: 1500
- From 1 Jan 2024 to the primary completion date, 30 Dec 2031
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous gastrectomy or major gastric surgery that substantially alters gastric anatomy and prevents reliable assessment of lesion location, intragastric distribution, or background mucosal status
Other illness
- 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
- 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
- Any other condition judged by the investigators to make the participant unsuitable for the study
Other
- Lack of adequate pathological material or pathological information for assessment of gastric lesion characteristics, tissue-based H. pylori detection, or background mucosal changes
- Pregnancy or breastfeeding for prospectively enrolled participants
- Inability or unwillingness to comply with study procedures or follow-up requirements for prospectively enrolled participants
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Gastroenterology, Rocket Force Characteristic Medical Center Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| First Medical Center of Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The Eighth Medical Center of Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.