Distribution Characteristics of Helicobacter Pylori

NCT07253948 | Recruiting DMC

• 1 other identifier: 130029
• Study Type: observational
• Target: 231
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori; Early Gastric Cancer

Keywords

Helicobacter pylori; Immunohistochemical staining; Atrophic gastritis; Early gastric cancer screening

Outcome Measures

Primary Outcomes (1)

• The status of Helicobacter pylori(H. pylori)

  The status of H. pylori included negative and positive status. Positve 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.

  one week after the endoscopic submucosal dissection (ESD)

Secondary Outcomes (1)

• the percentage of H. pylori positive status of gastric antrum in early gastric cancer

  one year after the endoscopic submucosal dissection (ESD)

Other Outcomes (3)

• the percentage of H. pylori positive status of gastric body in early gastric cancer

  one year after the endoscopic submucosal dissection (ESD)

• the percentage of H. pylori positive status of gastric antrum in gastritis

  one year after the endoscopic submucosal dissection (ESD)

• the percentage of H. pylori positive status of gastric body in gastritis

  one year after the endoscopic submucosal dissection (ESD)

Study Arms (1)

received H. pylori immunohistochemical testing at our center and tested positive

Diagnostic Test: immunohistochemical testing

Interventions

immunohistochemical testing DIAGNOSTIC_TEST

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.

received H. pylori immunohistochemical testing at our center and tested positive

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cases that underwent gastric H. pylori immunohistochemical staining at our center from March 1, 2023, to August 15, 2025.

You may qualify if:

• age 18-80 years
• received H. pylori immunohistochemical testing at our center and tested positive.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jilin University: lead

Study Sites (1)

the First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Gastritis, Atrophic

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastritis; Gastroenteritis

Central Study Contacts

Dong Yang, Doctor

CONTACT

86-18844097668; 714488468@qq.com

Hong Xu, Professor

CONTACT

0431-88782821; x_hong@jlu.edu.cn

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 28, 2025
• Study Start: October 22, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)