Prevention of gastric cancer by eradication of Helicobacter pylori infection

Study identification

• EU PAS number:
  EUPAS107327
• Study ID:
  108428
• Official title and acronym:
  Prevention of gastric cancer by eradication of Helicobacter pylori infection
• DARWIN EU® study:
  No
• Study countries:
  Slovenia
• Study description:
  The main goal of this observational study is to assess the feasibility of implementing the proposed "test-and-treat" screening program. The program has been proposed for an active infection with Helicobacter pylori (H. pylori) to prevent the development of gastric cancer in patients between 30-34 years of age. Patients will be randomly selected from a pool of potential respondents and invited to participate in the study by the chosen personal physician's registered nurse. Those patients who will provide their informed consent to participate will take an interview with a registered nurse about childhood risk factors and their habits regarding the consumption of alcohol and use of tobacco. Moreover, all participating patients will have serology taken to test on the presence of H. pylori antibodies. Patients with a positive serological test will take a confirmatory urea breath test (UBT) to diagnose them with a potential active infection with H. pylori. Patients with a confirmed active infection with H. pylori will be treated by bismuth-based quadriple therapy and the success of eradication will be tested by taking a second UBT during a control check-up. Patients with a positive result of the second UBT will be treated once more by a modified bismuth-based quadriple therapy, and the success of eradication will be retested by a third UBT during a second control check-up. Compliance to testing and treatment, the treatment results, adverse effects and reasons for dropping out of participation will be monitored for each of the participants. Research reports will be disseminated and results will be presented to the public and scientific community to foster future developments in gastric cancer prevention.
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Actual: 12/10/2022

Study start date

Planned: 04/12/2023

Actual: 01/02/2024

Date of final study report

Planned: 31/03/2025

Sources of funding

EU institutional research programme

Other

More details on funding

Ministry of Health, HaDEA: Eu4Health programme

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable