Gastric Cancer Clinical Trial
Official title:
Epidemiology of Helicobacter Pylori Infection in Moscow
NCT number | NCT05775120 |
Other study ID # | 4/2022-2 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2022 |
Est. completion date | January 15, 2025 |
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.
Status | Recruiting |
Enrollment | 5121 |
Est. completion date | January 15, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - • Age 18 to 80 years; - Signed informed consent form. Exclusion Criteria: - 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 1. Refusal of further use of the drug; 2. Deterioration of objective indicators of the patient's condition; |
Country | Name | City | State |
---|---|---|---|
Russian Federation | A.S. Loginov Moscow Clinical Scientific Center | Moscow |
Lead Sponsor | Collaborator |
---|---|
Moscow Clinical Scientific Center |
Russian Federation,
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Liou JM, Malfertheiner P, Lee YC, Sheu BS, Sugano K, Cheng HC, Yeoh KG, Hsu PI, Goh KL, Mahachai V, Gotoda T, Chang WL, Chen MJ, Chiang TH, Chen CC, Wu CY, Leow AH, Wu JY, Wu DC, Hong TC, Lu H, Yamaoka Y, Megraud F, Chan FKL, Sung JJ, Lin JT, Graham DY, W — View Citation
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Ogutmen Koc D, Bektas S. Serum pepsinogen levels and OLGA/OLGIM staging in the assessment of atrophic gastritis types. Postgrad Med J. 2022 Jun;98(1160):441-445. doi: 10.1136/postgradmedj-2020-139183. Epub 2020 Dec 30. — View Citation
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Sugano K, Tack J, Kuipers EJ, Graham DY, El-Omar EM, Miura S, Haruma K, Asaka M, Uemura N, Malfertheiner P; faculty members of Kyoto Global Consensus Conference. Kyoto global consensus report on Helicobacter pylori gastritis. Gut. 2015 Sep;64(9):1353-67. — View Citation
Yue H, Shan L, Bin L. The significance of OLGA and OLGIM staging systems in the risk assessment of gastric cancer: a systematic review and meta-analysis. Gastric Cancer. 2018 Jul;21(4):579-587. doi: 10.1007/s10120-018-0812-3. Epub 2018 Feb 19. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Develop recommendations for GC prevention and early detection strategy. | recommendations | 3 years | |
Primary | To assess the prevalence of the gastric mucosa atrophy using serological markers | (pepsinogen-I, pepsinogen-II and Gastrin-17) | upon inclusion | |
Primary | 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 | OLGA assessment of biopsy samples (pepsinogen I level less than 30 µg/l and/or pepsinogen I/pepsinogen II ratio less than 3). | 3 years | |
Secondary | To determine the prevalence of H. pylori in the Moscow population according to the non-invasive diagnostic method - 13C-urea breath test. | percent | 3 years | |
Secondary | To determine the prevalence of H. pylori in the Moscow population according to the serological method - level of IgG antibodies to H.pylori. | percent | 3 years |
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