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NCT Number: NCT06896370

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

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.

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Key information

Conditions

Gastric (Stomach) Cancer Bacterial Infections Bacterial Infections and Mycoses Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gram-Negative Bacterial Infections Helicobacter Infection Helicobacter Infections Infections Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observational study

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.

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.

    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).

Secondary 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.

    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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dazhi Xu, PhD

CONTACT

[email protected]

86-18121299796

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Mar 26, 2025
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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