An Observational Study for Gastric Cancer in Carriers of High Risk Helicobacter Pylori
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: observational study.
- Who it may be relevant to
- Registry conditions: Gastric (Stomach) Cancer, Helicobacter Infection. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Risk of Gastric Cancer in High-risk Carriers of Helicobacter Pylori: an Observational Cohort Study
Overview
This study is intended to be a prospective observational cohort study. The incidence of gastric cancer and progression of gastric precancerous lesions will be compared between groups through prospective follow-up of a population with baseline negative gastric endoscopy, harboring high-risk Hp SNP subtypes and non-high-risk subtypes.
Detailed description
Primary study objective: to assess the difference in the incidence of gastric cancer between carriers of high-risk SNP subtypes of H. pylori and the non-high-risk population during the follow-up period.
Secondary research objectives: 1. To observe and compare the cumulative incidence and progression of gastric precancerous lesions (e.g., atrophic gastritis, intestinal metaplasia, etc.) in each population group during the follow-up period.2. To explore the interaction of high-risk SNPs on the risk of gastric cancer in the context of different age, gender or other risk factors (e.g. diet, smoking, alcohol abuse, family history, etc.).
Interventions
- Other observational study
By prospectively following a population of asymptomatic carriers carrying high-risk Hp SNP subtypes and non-high-risk subtypes, the incidence of gastric cancer and progression of gastric precancerous lesions were compared between the groups.
Primary outcome measures
- Difference in incidence of gastric cancer between the three groups (HP positive high-risk, HP positive non-high-risk, and HP negative) during a 3-year follow-up. [Time frame: From enrollment to the end of the study in 3 years]
Secondary outcome measures (2)
- Difference in incidence of gastric cancer between the three groups (HP positive high-risk, HP positive non-high-risk, and HP negative) at 5-, and 10-year follow-up time points. [Time frame: From enrollment to the end of the study in 10 years]
- Differences in the incidence of gastric precancerous lesions among three groups (Hp-positive high-risk, Hp-positive non-high-risk, and Hp-negative) at 3-, 5-, and 10-year follow-up time points. [Time frame: From enrollment to the end of the study in 10 years]
Eligibility criteria
Inclusion criteria
- Age ≥ 40 years, gender is not limited.
- Able and willing to provide informed consent and willing to undergo baseline and follow-up examinations.
Exclusion criteria
- A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.
- 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.
- Severe mental illness or incapacity to participate in the study due to lack of civil behavior.
- Pregnant or breastfeeding women.
- Other conditions that the investigator deems inappropriate for participation in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- People's Hospital of Tongling City — Tongling
Identifiers
NCT: NCT06896370 · 2025 observational study