Helicobacter Pylori Infection Status and Pathological Features for Predicting Gastric Cancer Biological Behavior and Prognosis: A Real-World Observational Study
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-80 lat
- •Zdiagnozowany wczesny rak żołądka lub zmiana nowotworowa wymagająca leczenia endoskopowego
- •Dostępne wyniki badań na obecność bakterii H. pylori (test oddechu, badanie krwi lub badanie tkanki)
- •Dostępne wyniki biopsji tkanki żołądka
- •Pełne informacje o charakterze nowotworu i głębokości naciekania
- •Możliwość uczestnictwa w obserwacji przez co najmniej 3 lata
- •Odpowiednia funkcja serca, wątroby, nerek i płuc do tolerowania zabiegu
- •Zdolność do wyrażenia świadomej zgody na uczestnictwo w badaniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Last updated (source)
- July 24, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (3)
The Eighth Medical Center of Chinese PLA General Hospital
Beijing, China
First Medical Center of Chinese PLA General Hospital
Beijing, China
Department of Gastroenterology, Rocket Force Characteristic Medical Center
Beijing, China
Trial contact
He Zhou, PhD
Song Su, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/26/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.