Test-and-treat Helicobacter pylori for gastric cancer prevention

Study identification

• EU PAS number:
  EUPAS1000000144
• Study ID:
  1000000144
• Official title and acronym:
  Test-and-treat Helicobacter pylori for gastric cancer prevention
• DARWIN EU® study:
  No
• Study countries:
  Croatia

  Ireland

  Latvia

  Poland

  Romania

  Slovenia
• Study description:
  The aim of this multi-centric prospective study is to apply pilot test of a screening program for Helicobacter pylori (H. pylori) infection with the proposed test-and-treat strategy in patients between 30-34 years of age at 7 study sites in the European Union (EU). Although there are some differences in the study protocol between individual study sites, a common set of protocol characteristics is followed. Candidate patients will be sampled and invited to participate in the study and to sign the informed consent form. Enrolled participants at 5 screening sites will take a primary serology test, and those with a positive result will take an additional urea breath test (UBT) to confirm an active infection with H. pylori. In 2 remaining study sites only UBT will be used for confirmation. Participants with a positive UBT result will undergo primary treatment consisting of 2 antibiotics, a proton pump inhibitor and, in 6 out of 7 study centers, colloidal bismuth. The success of eradication will be afterwards tested by a control UBT. Participants with persisting infection will undergo secondary treatment consisting of 2 antibiotics, a proton pump inhibitor and, in 6 out of 7 study centers, colloidal bismuth, and will be re-tested for eradication by second control UBT. All study sites will collect data on the rate of H. pylori eradication, medication adherence and occurrence of adverse events, where NIJZ will enable information technology and data base support. We estimate that the project's prospective cohort will consist of up to 6,800 study participants. All study sites obtained the approval of their local ethics committee. The results of this study will provide evidence-based foundation for the preparation of screening recommendations to implement this strategy within EU as a screening program according to special conditions (EU Recommendation) to reduce the burden of gastric cancer and other health problems associated with H. pylori infection.
• Study status:
  Ongoing

Research institutions and networks

Institutions

National Institute of Public Health (NIJZ)

Slovenia

- Beacon Hospital
- Clinical Hospital Center Rijeka
- "Iuliu Hatieganu" University of Medicine and Pharmacy Cluj-Napoca
- University Hospital Centre Zagreb
- University of Latvia Institute of Clinical and Preventive Medicine
- Wroclaw Medical University.

Study timelines

Date when funding contract was signed

Planned:14/02/2023

Study start date

Planned:01/02/2024

Actual:04/03/2024

Date of final study report

Planned:31/03/2026

Sources of funding

EU institutional research programme

Other

More details on funding

1. HaDEA: Eu4Health programme
2. Ministry of Health

Regulatory

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