Epidemiology of Helicobacter Pylori Infection in Moscow

NCT05775120 | Unknown

• 1 other identifier: 4/2022-2
• Study Type: observational
• Target: 5,121
• Locations: 1 country
• Sites: 1

Brief 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

Gastric Atrophy; Gastric Cancer; Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (2)

• To assess the prevalence of the gastric mucosa atrophy using serological markers

  (pepsinogen-I, pepsinogen-II and Gastrin-17)

  upon inclusion

• 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 Outcomes (2)

• 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

Other Outcomes (1)

• Develop recommendations for GC prevention and early detection strategy.

  3 years

Study Arms (2)

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. Based on pepsinogen (PG) I levels and PG II (serological markers of atrophy of the gastric mucosa), patients with a high risk of atrophic gastritis and precancerous lesions in the gastric mucosa will be identified and the age and sex structure of atrophic gastritis prevalence in Moscow will be constructed.

Cohort 2

From 5121 respondents, 500 patients with confirmed H. pylori infection and serological markers of atrophic gastritis and a control group of infected with H. pylori without serological markers of gastric mucosa atrophy will be selected. They will undergo esophagogastroduodenoscopy with two gastric mucosa biopsies. The first will be conducted according to the OLGA system with a pathology assessment of the stage and degree of gastritis, while the second will be taken to determine the antimicrobial susceptibility of H. (polymerase chain reaction and culture). Correlations between serological and patholgy data on atrophy will be assessed in order to determine the reliability of serological screening for atrophy in the Moscow population.

Diagnostic Test: OLGA and H.pylori culture

Interventions

OLGA and H.pylori culture DIAGNOSTIC_TEST

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).

Cohort 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Screening for H. pylori infection is planned in 5121 citizens living in different administrative districts of Moscow.

You may qualify if:

• Age 18 to 80 years;
• Signed informed consent form.

You may not qualify if:

• 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;
• Refusal of further use of the drug;
• Deterioration of objective indicators of the patient's condition;

Sponsors & Collaborators

• Moscow Clinical Scientific Center: lead

Study Sites (1)

A.S. Loginov Moscow Clinical Scientific Center

Moscow, Russia

RECRUITING

Related Publications (12)

• Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.

  PMID: 27707777 RESULT

• 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. doi: 10.1136/gutjnl-2015-309252. Epub 2015 Jul 17.

  PMID: 26187502 RESULT

• 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, Wu MS, El-Omar EM; Asian Pacific Alliance on Helicobacter and Microbiota (APAHAM). Screening and eradication of Helicobacter pylori for gastric cancer prevention: the Taipei global consensus. Gut. 2020 Dec;69(12):2093-2112. doi: 10.1136/gutjnl-2020-322368. Epub 2020 Oct 1.

  PMID: 33004546 RESULT

• Best LM, Takwoingi Y, Siddique S, Selladurai A, Gandhi A, Low B, Yaghoobi M, Gurusamy KS. Non-invasive diagnostic tests for Helicobacter pylori infection. Cochrane Database Syst Rev. 2018 Mar 15;3(3):CD012080. doi: 10.1002/14651858.CD012080.pub2.

  PMID: 29543326 RESULT

• Pimentel-Nunes P, Libanio D, Marcos-Pinto R, Areia M, Leja M, Esposito G, Garrido M, Kikuste I, Megraud F, Matysiak-Budnik T, Annibale B, Dumonceau JM, Barros R, Flejou JF, Carneiro F, van Hooft JE, Kuipers EJ, Dinis-Ribeiro M. Management of epithelial precancerous conditions and lesions in the stomach (MAPS II): European Society of Gastrointestinal Endoscopy (ESGE), European Helicobacter and Microbiota Study Group (EHMSG), European Society of Pathology (ESP), and Sociedade Portuguesa de Endoscopia Digestiva (SPED) guideline update 2019. Endoscopy. 2019 Apr;51(4):365-388. doi: 10.1055/a-0859-1883. Epub 2019 Mar 6.

  PMID: 30841008 RESULT

• De Re V, Orzes E, Canzonieri V, Maiero S, Fornasarig M, Alessandrini L, Cervo S, Steffan A, Zanette G, Mazzon C, De Paoli P, Cannizzaro R. Pepsinogens to Distinguish Patients With Gastric Intestinal Metaplasia and Helicobacter pylori Infection Among Populations at Risk for Gastric Cancer. Clin Transl Gastroenterol. 2016 Jul 21;7(7):e183. doi: 10.1038/ctg.2016.42.

  PMID: 27441820 RESULT

• 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.

  PMID: 33380437 RESULT

• Megraud F, Bruyndonckx R, Coenen S, Wittkop L, Huang TD, Hoebeke M, Benejat L, Lehours P, Goossens H, Glupczynski Y; European Helicobacter pylori Antimicrobial Susceptibility Testing Working Group. Helicobacter pylori resistance to antibiotics in Europe in 2018 and its relationship to antibiotic consumption in the community. Gut. 2021 Oct;70(10):1815-1822. doi: 10.1136/gutjnl-2021-324032. Epub 2021 Apr 9.

  PMID: 33837118 RESULT

• Savoldi A, Carrara E, Graham DY, Conti M, Tacconelli E. Prevalence of Antibiotic Resistance in Helicobacter pylori: A Systematic Review and Meta-analysis in World Health Organization Regions. Gastroenterology. 2018 Nov;155(5):1372-1382.e17. doi: 10.1053/j.gastro.2018.07.007. Epub 2018 Jul 7.

  PMID: 29990487 RESULT

• 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.

  PMID: 29460004 RESULT

• Rugge M, Fassan M, Pizzi M, Zorzetto V, Maddalo G, Realdon S, De Bernard M, Betterle C, Cappellesso R, Pennelli G, de Boni M, Farinati F. Autoimmune gastritis: histology phenotype and OLGA staging. Aliment Pharmacol Ther. 2012 Jun;35(12):1460-6. doi: 10.1111/j.1365-2036.2012.05101.x. Epub 2012 Apr 22.

  PMID: 22519568 RESULT

• Sawaki K, Kanda M, Kodera Y. Review of recent efforts to discover biomarkers for early detection, monitoring, prognosis, and prediction of treatment responses of patients with gastric cancer. Expert Rev Gastroenterol Hepatol. 2018 Jul;12(7):657-670. doi: 10.1080/17474124.2018.1489233. Epub 2018 Jun 25.

  PMID: 29902383 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

gastric mucosa biopsy for OLGA-assessment and culture (H.p. atimicrobal susceptibility)

MeSH Terms

Conditions

Gastritis, Atrophic; Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Dmitry S. Bordin, MD, PhD

  A.S. Loginov Moscow Clinical Research Center

  STUDY DIRECTOR

Central Study Contacts

Dmitry S. Bordin, MD, PhD

CONTACT

+79262311603; d.bordin@mknc.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: July 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: January 15, 2025
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

RU (1)