Gastric cancer risk in carriers of high-risk Helicobacter pylori variants
Risk of Gastric Cancer in High-risk Carriers of Helicobacter Pylori: an Observational Cohort Study
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 |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Tongling) |
| Trial ID | NCT06896370 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tongling
- People's Hospital of Tongling City — Tongling, China (Recruiting)
Study contacts
- Study coordinator: Dazhi Xu, PhD
- Email: xudzh@fudan.edu.cn
- Phone: 86-18121299796
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.