Actively Recruiting
Risk of Gastric Cancer in High-risk Carriers of Helicobacter Pylori: an Observational Cohort Study
Led by Fudan University · Updated on 2026-02-25
3000
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective observational cohort study to compare the incidence of gastric cancer and the progression of gastric precancerous lesions among groups with different Helicobacter pylori (Hp) genetic subtypes. The study focuses on adults aged 40 and older who have a baseline negative gastric endoscopy and are either carriers of high-risk Hp SNP subtypes, non-high-risk subtypes, or are Hp negative. The goal is to understand how these genetic differences impact gastric cancer risk over time. Participants are followed prospectively in three groups: those who are Hp positive with high-risk SNP subtypes, those Hp positive with non-high-risk SNP subtypes, and those who are Hp negative. The study does not involve any treatment but monitors the natural progression of gastric conditions associated with these groups. Follow-up assessments occur over a period of up to 10 years, with primary and secondary outcomes measured at 3, 5, and 10 years. During the study, participants undergo baseline and follow-up examinations to monitor the incidence of gastric cancer and the development of precancerous lesions such as atrophic gastritis and intestinal metaplasia. Researchers also examine how factors like age, gender, diet, smoking, alcohol use, and family history might interact with Hp genetic risk. The primary outcome focuses on the difference in gastric cancer incidence among the groups during a 3-year follow-up, while secondary outcomes consider longer-term incidence and lesion progression. Participants' safety and ability to continue in the study are monitored throughout the follow-up period.
CONDITIONS
Brief Title
An Observational Study for Gastric Cancer in Carriers of High Risk Helicobacter Pylori
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older
- Able and willing to provide informed consent
- Willing to undergo baseline and follow-up examinations
You will not qualify if you...
- History of diagnosed gastric cancer or other digestive tract cancers
- Severe heart, lung, liver, or kidney conditions likely to limit life expectancy or follow-up
- Severe mental illness or inability to participate due to lack of civil behavior
- Pregnant or breastfeeding women
- Other conditions deemed inappropriate for study participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 10 years
Participants who carry high-risk or non-high-risk Helicobacter pylori subtypes or are HP negative are observed to monitor the incidence and progression of gastric cancer and precancerous lesions.
Periodic assessments during follow-up visits
Trial Site Locations
Total: 1 location
1
People's Hospital of Tongling City
Tongling, China
Actively Recruiting
Research Team
D
Dazhi Xu, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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