Helicobacter Pylori InfectionEUGastScreenNCT07873580
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
An observational study of Helicobacter Pylori Infection and Colorectal Cancer, run by University of Latvia.
Trial summary
The EUGastScreen study is designed as a quality implementation study to explore gastric cancer screening strategies within organised cancer screening frameworks. The study is set to target individuals who are entering the age range for CRC screening, integrating gastric cancer screening into this existing structure. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection, Colorectal Cancer, Gastric Cancer
- What is being tested?
- Fecal sample acquisition for Helicobacter pylori stool antigen test, Upper endoscopy with biopsies and Colonoscopy with biopsies after bowel cleansing
- How many people
- 8,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Mar 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: National healthcare screening databases will be utilized for selecting study participants. The study population will generally be selected from a pre-defined geographical area to ensure access to necessary study facilities. The following regions have been identified as initial study centres: Original pilot sites Estonia - Tallinn city and Harjumaa municipality; Italy (Marche) - Marche Region - Macerata District; Latvia - Riga city, Jēkabpils region and Aizkraukle, Madona, Varakļāni, Līvāni municipalities; Portugal - North of Portugal, Santo Tirso (Medio Ave Local Health Unit; Barcelos-Esposende Local Health Unit). Additional pilot sites Italy (Bologna) - Emilia-Romagna Region - Bologna District; Lithuania - Vilnius city municipality.
Who may be able to join
- age 50 years and above (the actual recruitment age corresponds to the first CRC-screening age in each participating country/region);
Who cannot join
- personal history of gastric cancer;
- personal history of colorectal cancer;
- successfully screened via national colorectal cancer screening programme;
- inability or unwillingness to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The EUGastScreen study is designed as a quality implementation study to explore gastric cancer screening strategies within organised cancer screening frameworks. The study is set to target individuals who are entering the age range for CRC screening, integrating gastric cancer screening into this existing structure.
- Being tested
- Fecal sample acquisition for Helicobacter pylori stool antigen test, Upper endoscopy with biopsies, Colonoscopy with biopsies after bowel cleansing, Helicobacter pylori eradication therapy, Fecal sample acquisition for Fecal Immunochemical test
- Keywords
- Helicobacter pylori, Stool antigen test, Fecal immunochemical test, Combined screening, Gastric cancer prevention
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal sample acquisition for Helicobacter pylori stool antigen testDiagnostic test
Participants will be offered to perform Helicobacter pylori (H. pylori) Stool antigen test (SAT) for H. pylori infection identification. SAT may be used after eradication therapy to confirm H. pylori eradication success instead of 13C Urea Breath Test.
Upper endoscopy with biopsiesDiagnostic test
Upper endoscopy will be offered to participants with positive family history and/or alarm symptoms if such are identified (SAT and FIT negative individuals may not undergo questioning for the presence of alarm symptoms), provided a quality-assured endoscopic procedure has not been performed recently.
Colonoscopy with biopsies after bowel cleansingDiagnostic test
Colonoscopy will be offered to participants with positive FIT results, or positive family history, provided a quality-assured endoscopic procedure has not been performed recently; or such participants will be managed within national CRC screening programme.
Helicobacter pylori eradication therapyDrug
Helicobacter pylori eradication (antimicrobial) therapy offered to participants with Stool antigen test positive results.
The recommended approach for first line treatment is bismuth quadruple therapy for 10-14 days, combined with a high-dose PPI BID. The recommended second line eradication medication: Levofloxacin-based quadruple/triple for 14 days plus high-dose PPI BID.
Fecal sample acquisition for Fecal Immunochemical testDiagnostic test
Participants will be offered Fecal Immunochemical test for colorectal cancer screening.
Breath sample acquisition for 13C Urea Breath TestDiagnostic test
13C Urea Breath test will be offered to participants at least 4 weeks after Helicobacter pylori eradication therapy end for eradication success control.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Subjects eligible for participation in national colorectal cancer screening programme Receives: Diagnostic Test: Fecal sample acquisition for Helicobacter pylori stool antigen test; Diagnostic Test: Upper endoscopy with biopsies; Diagnostic Test: Colonoscopy with biopsies after bowel cleansing; Drug: Helicobacter pylori eradication therapy; Diagnostic Test: Fecal sample acquisition for Fecal Immunochemical test; Diagnostic Test: Breath sample acquisition for 13C Urea Breath Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of invited individuals who return a Stool antigen test (SAT) sample.
Number of invited individuals who return a SAT sample divided by the number invited, multiplied by 100.
Measured: Within 30 days after test kit distribution, according to site-specific procedures.
Percentage of eligible individuals who receive a study invitation
Number of eligible individuals who receive a study invitation divided by the number of eligible individuals identified for invitation, multiplied by 100.
Measured: During the study recruitment period, up to 12 months.
Percentage of stool antigen test (SAT)-positive participants who start Helicobacter pylori Eradication Therapy
Number of SAT-positive participants who start eradication therapy divided by the number of SAT-positive participants, multiplied by 100.
Measured: From positive SAT result through initiation of eradication therapy, up to 12 months
Helicobacter pylori eradication rate
Number of SAT-positive participants offered eradication therapy who have a negative post-treatment confirmatory test (stool antigen test or 13C-urea breath test), divided by the number of SAT-positive participants offered therapy, multiplied by 100.
Measured: At least 4 weeks after completion of eradication therapy, up to 12 months
Participant-reported reasons for participation in or refusal of Helicobacter pylori testing
Participant-reported reasons for participation in or refusal of Helicobacter pylori testing, summarized by response category.
Measured: At the screening participation decision.
Secondary outcomes (14)
Percentage of participants who take at least 90% of prescribed eradication therapy
Number of participants who take at least 90% of prescribed doses, divided by the number who start therapy, multiplied by 100.
Measured: From initiation through completion of eradication therapy (10-14 days)
Percentage of referred participants who undergo upper gastrointestinal endoscopy
Number of participants referred for upper gastrointestinal endoscopy who undergo the procedure divided by the number of participants referred for upper gastrointestinal endoscopy, multiplied by 100.
Measured: Through study completion, an average of 1 year
Percentage of participants meeting criteria for referral to upper gastrointestinal endoscopy
Number of participants meeting protocol-defined criteria for referral to upper gastrointestinal endoscopy divided by the number of participants assessed for the applicable referral criteria, multiplied by 100.
Measured: At initial screening assessment
Percentage of returned Stool antigen test (SAT) samples not valid for testing
Number of returned SAT samples rejected as invalid divided by the total number returned, multiplied by 100.
Measured: Through study completion, an average of 1 year
Reasons for invalid Stool Antigen Test (SAT) samples
Reasons returned SAT samples are considered invalid for testing, including late return and inappropriate sample collection, summarized by reason category.
Measured: Through study completion, an average of 1 year
Percentage of Fecal immunochemical test (FIT)-positive participants who undergo follow-up colonoscopy
Number of FIT-positive participants who undergo colonoscopy divided by the number of FIT-positive participants, multiplied by 100.
Measured: Through study completion, an average of 1 year
Colonoscopy findings among Fecal immunochemical test (FIT)-positive participants undergoing follow-up colonoscopy
Colonoscopy findings among FIT-positive participants who undergo follow-up colonoscopy, summarized by finding category.
Measured: Through study completion, an average of 1 year
Helicobacter pylori positivity by Stool antigen test (SAT) among participants
Number of participants with a positive SAT divided by the number with a valid SAT result, multiplied by 100.
Measured: Through study completion, an average of 1 year
Percentage of participants with a positive Fecal Immunochemical Test (FIT)
Number of participants with a positive FIT result divided by the number of participants with a valid FIT result, multiplied by 100.
Measured: Through study completion, an average of 1 year
Percentage of invited individuals who return a Fecal Immunochemical Test (FIT) sample
Number of invited individuals who return a FIT sample divided by the number of invited individuals, multiplied by 100.
Measured: Through study completion, an average of 1 year
Percentage of participants who complete post-treatment H. pylori eradication confirmation testing
Number of participants who complete post-treatment confirmatory testing divided by the number of participants eligible for post-treatment confirmatory testing, multiplied by 100.
Measured: At least 4 weeks after completion of eradication therapy, up to 12 months
Reasons for non-completion of H. pylori eradication therapy
Participant-reported reasons for completing less than 90% of the prescribed eradication therapy, including self-reported adverse effects and other factors contributing to discontinuation.
Measured: During eradication therapy (10-14 days).
Upper gastrointestinal endoscopic findings
Endoscopic findings among participants who undergo upper gastrointestinal endoscopy, summarized by finding category.
Measured: Through study completion, an average of 1 year
Upper gastrointestinal histological findings
Histological findings among participants with biopsy specimens obtained during upper gastrointestinal endoscopy, summarized by finding category.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Latvia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Development, Estonia, University of Bologna, National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos, Instituto Portugues de Oncologia, Francisco Gentil, Porto, Agenzia Regionale Sanitaria delle Marche
- Responsible party
- Sponsor
- Investigators
- Marcis Leja, Professor, Principal investigator, University of Latvia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873580
- Sponsor's protocol ID
- 7-A/26
- Other IDs
- 101162959
- Acronym
- EUGastScreen
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be made generally available to other researchers. Data may be shared with authorized research partners only as permitted by the study protocol and applicable data governance framework, subject to participant consent and ethical approval where applicable, appropriate data-sharing agreements, and data protection requirements