Epidemiology of Helicobacter Pylori Infection in Moscow
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,121
- 试验地点
- 1
- 主要终点
- To assess the prevalence of the gastric mucosa atrophy using serological markers
研究概览
简要总结
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.
详细描述
Aim: to analyze the prevalence of H. pylori infection and pre-neoplastic lesions in the gastric mucosa in the Moscow population to develop a strategy for gastric cancer and early detection.
Main goals:
- To determine the prevalence of H. pylori in the Moscow population according to the non-invasive diagnostic method - 13C-urea breath test.
- To determine the prevalence of H. pylori in the Moscow population according to the serological method - level of IgG antibodies to H.pylori.
- To assess the prevalence of the gastric mucosa atrophy using serological markers (pepsinogen-I, pepsinogen-II and Gastrin-17) in the different age groups of the Moscow population.
- To assess the state of the gastric mucosa according to endoscopic and morphological studies using the OLGA system, and their correlation with serological markers of atrophy (pepsinogen I level less than 30 µg/l and/or pepsinogen I/pepsinogen II ratio less than 3).
- Develop recommendations for GC prevention and early detection strategy.
The planned study will contain two sample cohorts:
Cohort 1 Screening for H. pylori infection is planned in 5121 citizens living in different administrative districts of Moscow. The cohort will be formed based on age and sex structure of the Moscow population. The presence of H. pylori will be analyzed using 2 non-invasive methods - 13C-urease breath test and serological test (detection of IgG antibodies to H. pylori). An epidemiological questionnaire will be filled out for each respondent which will display basic information on the patient (gender, age, eating habits, bad habits, family history of cancer, etc.), as well as characterize the main symptoms, if any.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Age 18 to 80 years;
- •Signed informed consent form.
排除标准
- •Criteria for non-inclusion:
- •history of taking antibiotics, bismuth-containing drugs within 30 days before the visit and proton pump inhibitors within 14 days before the visit;
- •The presence of clinically significant neurological, cardiovascular, gastrointestinal (total of partial gastrectomy), hepatic, renal, immune and other diseases in medical history;
- •Patients with diagnosed cancers of any kind who require specialized treatment and/or are currently undergoing anticancer treatment;
- •Psychiatric illnesses, including in the past, which, in the opinion of the investigator, make the patient's participation in the study unacceptable;
- •Pregnancy;
- •Patients who tend to refuse to participate in the study and comply with doctor's recommendations;
- •Inability or unwillingness to give informed consent to participate in the study or to fulfill the requirements of the study;
- •Criteria for exclusion of patients from the study
- •Refusal of further use of the drug;
- •Deterioration of objective indicators of the patient's condition;
结局指标
主要结局
To assess the prevalence of the gastric mucosa atrophy using serological markers
时间窗: upon inclusion
(pepsinogen-I, pepsinogen-II and Gastrin-17)
To assess the state of the gastric mucosa according to endoscopic and morphological studies using the OLGA system, and their correlation with serological markers of atrophy
时间窗: 3 years
OLGA assessment of biopsy samples (pepsinogen I level less than 30 µg/l and/or pepsinogen I/pepsinogen II ratio less than 3).
次要结局
- To determine the prevalence of H. pylori in the Moscow population according to the non-invasive diagnostic method - 13C-urea breath test.(3 years)
- To determine the prevalence of H. pylori in the Moscow population according to the serological method - level of IgG antibodies to H.pylori.(3 years)