An Observational Study for Gastric Cancer in Carriers of High Risk Helicobacter Pylori
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 40 years, gender is not limited.
Able and willing to provide informed consent and willing to undergo baseline and follow-up examinations.
Disqualifiers
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.
Trial population
Subjects were recruited from communities in Tongling, Anhui Province.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
observational study
Other interventionBy 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.
Treatment groups
3,000 Participants
are divided into 3 treatment groupsGroup A: exposure group1 intervention
Group B: Control 11 intervention
Group C: Control 21 intervention
Trial outcomes
Primary outcomes
1
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.
Evaluate the difference in the incidence of gastric cancer between high-risk and non-high-risk groups, while considering the comparison with the HP negative group. The comparison between the three groups (HP positive high-risk, HP positive non-high-risk, and HP negative) will assess the difference in gastric cancer incidence during a 3-year follow-up. Gastric cancer incidence will be determined based on pathological confirmation (biopsy results).
Time frame
From enrollment to the end of the study in 3 yearsSecondary outcomes
1
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.
Evaluate the difference in the incidence of gastric cancer between high-risk and non-high-risk groups, while considering the comparison with the HP negative group. The comparison between the three groups (HP positive high-risk, HP positive non-high-risk, and HP negative) will assess the difference in gastric cancer incidence at 5-, and 10-year follow-up time points. Gastric cancer incidence will be determined based on pathological confirmation (biopsy results).
Time frame
From enrollment to the end of the study in 10 years2
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.
Evaluate the difference in the incidence of precancerous lesions between high-risk and non-high-risk groups at 3-, 5-, and 10-year follow-up time points, while considering the HP negative group. This comparison will also help assess the effect of HP infection on the development of precancerous lesions.
Time frame
From enrollment to the end of the study in 10 yearsSponsors and contacts
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Source ClinicalTrials.gov