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Clinical Trials in China / NCT07253948
Recruiting Observational

Distribution Characteristics of Helicobacter Pylori

NCT07253948 · tracked via the Priya Life Science China tracker
Sponsor
Jilin University
Phase
Observational
Started
2025-10-22
Last updated
2025-11-28

Condition(s) studied

Helicobacter PyloriEarly Gastric Cancer

Investigational drug(s) / intervention(s)

immunohistochemical testing

immunohistochemical testing: Immunohistochemical results were reviewed independently by two experienced pathologists, with disagreements resolved by a third. Immunohistochemical staining was performed using an anti-H. pylori antibody (Beijing Zhongshan Golden Bridge Biotechnology Co., Ltd, Beijing, China). Positive results were graded as mild (1+): occasional bacteria or colonization in \<1/3 of the specimen length; moderate (2+): colonization exceeding 1/3 but \<2/3 of the specimen, or continuous but sparse distribution on the epithelial surface; and severe (3+): clusters of H. pylori distributed across the full length of the specimen. The gastric body and antrum were assessed separately, and distribution patterns were classified as gastric antrum \> gastric body, gastric antrum = gastric body, or gastric body \> gastric antrum. The distribution of H. pylori across subgroups was compared, and multivariate analyses were performed to identify risk factors associated with the development of early gastric cancer.

Study summary

This study aimed to analyze the distribution characteristics of Helicobacter pylori(H. pylori) in varying stages of atrophic gastritis and early gastric cancer using immunohistochemical staining, with the goal of providing guidance for the early screening of gastric cancer.

A retrospective analysis was conducted on gastric biopsy cases that underwent H. pylori immunohistochemical staining at our center from March 1, 2023, to August 15, 2025. Cases were classified into non-atrophic and atrophic groups based on the presence or absence of gastric atrophy. All cases were further divided into non-open and open atrophy groups and additionally into early gastric cancer and non-cancer groups. The distribution of H. pylori across subgroups was compared, and multivariate analyses were performed to identify risk factors associated with the development of early gastric cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * age 18-80 years * received H. pylori immunohistochemical testing at our center and tested positive. Exclusion Criteria: * biopsies not collected from both the greater and lesser curvatures of the gastric antrum and body * history of stomach surgery * suspected autoimmune gastritis under endoscopy * liver cirrhosis * severe comorbidities such as advanced cancer or renal failure * advanced gastric cancer or gastric lymphoma

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
the First Hospital of Jilin University Changchun Jilin Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07253948 on ClinicalTrials.gov ↗ ← All trials in China