Gastric cancer risk in carriers of high-risk Helicobacter pylori variants
Official title: Risk of Gastric Cancer in High-risk Carriers of Helicobacter Pylori: an Observational Cohort Study
Run by Fudan University · NCT06896370 · Data updated 2026-11-12
This study will see if people carrying high‑risk genetic subtypes of H. pylori develop gastric cancer or precancerous lesions more often than people without those subtypes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Tongling) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | May 1, 2035 |
| Study ends | December 31, 2035 |
| Registry record updated | February 25, 2026 |
| Trial ID | NCT06896370 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 40 or older who can give informed consent, are willing to undergo baseline and follow‑up gastric exams, and do not have a prior diagnosis of gastric or other digestive tract cancer are ideal candidates.
✕Probably not a fit
People with prior gastric cancer, severe life‑limiting comorbidities, severe mental illness, pregnant or breastfeeding women, or those unwilling/unable to complete follow‑up or endoscopy are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational cohort that follows adults with a baseline negative gastric endoscopy and classifies them by H. pylori SNP subtype (high‑risk vs non‑high‑risk). Participants will undergo regular follow‑up examinations to record new cases of gastric cancer and the progression of precancerous lesions such as atrophic gastritis and intestinal metaplasia. The primary comparison is the incidence of gastric cancer between the two genetic-subtype groups over the follow‑up period. Secondary analyses will track cumulative incidence and lesion progression and explore interactions between H. pylori SNP risk status and factors like age, sex, diet, smoking, alcohol use, and family history.
Why it matters
Potential benefit: If successful, this could help identify people with H. pylori genetic subtypes who are at higher risk and who might benefit from closer surveillance or preventive strategies.
How similar studies have gone: Previous observational work has linked H. pylori virulence variants to higher gastric cancer risk, but prospective cohort data focused on specific high‑risk SNP subtypes remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria : 1. Age ≥ 40 years, gender is not limited. 2. Able and willing to provide informed consent and willing to undergo baseline and follow-up examinations. Exclusion Criteria: 1. A history of diagnosed gastric cancer or other malignant tumors of the digestive tract. 2. Comorbid severe underlying conditions (e.g., severe cardiopulmonary insufficiency, liver or renal failure, etc.) that are likely to result in a short life expectancy or render long-term follow-up impractical. 3. Severe mental illness or incapacity to participate in the study due to lack of civil behavior. 4. Pregnant or breastfeeding women. 5. Other conditions that the investigator deems inappropriate for participation in the study.
Where it's running
-
People's Hospital of Tongling City
Tongling, China Recruiting
Study contacts
- Study coordinator: Dazhi Xu, PhD
- Email: xudzh@fudan.edu.cn
- Phone: 86-18121299796
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.