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

February 23, 2026 updated by: Dazhi Xu, Fudan University

Risk of Gastric Cancer in High-risk Carriers of Helicobacter Pylori: an Observational Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.).

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Tongling, China
        • Recruiting
        • People's Hospital of Tongling City
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Subjects were recruited from communities in Tongling, Anhui Province.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control 1
Hp positive + non-high risk SNP
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.
Control 2
Hp negative
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.
exposure group
HP positive with high-risk SNP subtypes
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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).
From enrollment to the end of the study in 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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).
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
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.
From enrollment to the end of the study in 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

May 1, 2035

Study Completion (Estimated)

December 31, 2035

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025 observational study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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