An Observational Study for Gastric Cancer in Asymptomatic Carriers of High Risk Helicobacter Pylori

NCT ID: NCT06896370

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 6000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2035-12-31

Brief Summary

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 of asymptomatic carriers 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 asymptomatic 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.).

Conditions

Gastric (Stomach) Cancer; Helicobacter Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

exposure group

Hp positive + high risk SNP

observational study

Intervention Type: OTHER

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.

Control 1

Hp positive + non-high risk SNP

observational study

Intervention Type: OTHER

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.

Control 2

Hp negative

observational study

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years old, gender is not limited;

2. No previous history of gastric cancer (no radical surgery or radiotherapy treatment for gastric cancer);

3. Able and willing to provide informed consent and willing to accept baseline and follow-up examinations;

4. Able to cooperate in completing HP testing (breath test, gastroscopic biopsy or other standard testing methods) and HP SNP typing by stool testing;

5. No obvious gastric symptoms at the time of initial screening, no progressive gastric cancer or serious gastric diseases (e.g., perforated acute ulcers, upper gastrointestinal hemorrhage, etc.) detected, and no need for urgent surgery (not planned within 3 months) or other therapeutic interventions for the time being.

Exclusion Criteria

1. Diagnosed gastric cancer or other malignant tumors of the digestive tract;

2. Comorbid serious underlying diseases (e.g., severe cardiopulmonary insufficiency, liver and renal failure, etc.) that are expected to have a short survival time or are not suitable for long-term follow-up;

3. Inability to complete or refusal to undergo HP testing, SNP gene testing or follow-up;

4. Presence of severe mental illness or incapacity for civil behavior that prevents completion of the study;

5. Pregnant or breastfeeding women who are temporarily excluded;

6. Other conditions that the investigator considers unsuitable for participation in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Dazhi Xu

Dazhi Xu

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2025observational study

Identifier Type: -

Identifier Source: org_study_id