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Epidemiology of Helicobacter Pylori Infection in Moscow

NCT05775120 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 5121

Last updated 2023-03-20

No results posted yet for this study

Summary

H. pylori is transmitted from individual to individual and causes chronic active gastritis in all infected people. H. pylori infection can result in gastroduodenal ulcers, atrophic gastritis (AG), gastric carcinoma, and gastric MALT lymphoma.

More than 90% of gastric carcinomas are linked to H. pylori infection that causes chronic AG. A long course of the disease leads to the loss of gastric glands (chronic AG) followed by gastric intestinal metaplasia (GIM), dysplasia, and cancer. This defines two cancer prevention strategies: primary that consists of detection and eradication of H. pylori and secondary that focuses on endoscopic screening for pre-neoplastic lesions and follow-up.

Primary prevention planning requires reliable information on the H. pylori prevalence in the population. To design secondary prevention measures, an understanding of the age-sex structure of precancerous changes in the gastric mucosa (the prevalence of atrophic gastritis) is necessary.

H. pylori eradication is the basis of primary prevention of gastric cancer (GC). Approximately 36,000 new cases of GC are registered in the Russian Federation each year, and more than 34,000 patients die from the disease. Men get sick 1.3 times more often than women, the peak incidence occurs at the age of over 50 years. The poor outcomes reflect the late stage of diagnosis of this potentially preventable and treatable cancer. The lack of up-to-date data on the H. pylori prevalence in Moscow hinders developing of measures for the detection and timely treatment of this infection as well as the reduction of GC morbidity and mortality.

Conditions

Interventions

DIAGNOSTIC_TEST

OLGA and H.pylori culture

Upper endoscopy will be performed by endoscopists using modern endoscopes (Fujinon EG-590WR, Olimpus GIF-H190 and others) while patient is sedated. Using sterile biopsy forceps, biopsy specimens will be taken from five areas of the stomach (two biopsy specimens - greater and lesser curvature of the antrum of the stomach; two biopsy specimens - lesser and greater curvature (or anterior and posterior wall) of the body of the stomach and one from the corner of the stomach) for pathology assessment. Pathology assessment of the gastritis stage and degree will be conducted according to the OLGA system developed by the international group of gastroenterologists and pathologists (Atrophy Club).

Sponsors & Collaborators

  • Moscow Clinical Scientific Center

    lead OTHER

Principal Investigators

  • Dmitry S. Bordin, MD, PhD · A.S. Loginov Moscow Clinical Research Center

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2024-12-31
Completion
2025-01-15

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05775120 on ClinicalTrials.gov