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Not yet recruitingNCT07873580EUGastScreenUpdated Oct 14, 2026

European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers

An observational study in Helicobacter Pylori Infection, Colorectal Cancer and Gastric Cancer, sponsored by University of Latvia. Not yet recruiting. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by University of Latvia · Observational

Updated Oct 14, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
8,000
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Helicobacter Pylori Infection
  • Colorectal Cancer
  • Gastric Cancer

Keywords

  • Helicobacter pylori
  • Stool antigen test
  • Fecal immunochemical test
  • Combined screening
  • Gastric cancer prevention
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's planned enrollment of 8,000 is above the median of 250 across 1,253 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

University of Latvia is the lead sponsor of 8 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age 50 years and above (the actual recruitment age corresponds to the first CRC-screening age in each participating country/region);

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
8,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Participants

    Subjects eligible for participation in national colorectal cancer screening programme

    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

Interventions

  • Diagnostic testFecal sample acquisition for Helicobacter pylori stool antigen 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.

  • Diagnostic testUpper endoscopy with biopsies

    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.

  • Diagnostic testColonoscopy with biopsies after bowel cleansing

    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.

  • DrugHelicobacter pylori eradication therapy

    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.

  • Diagnostic testFecal sample acquisition for Fecal Immunochemical test

    Participants will be offered Fecal Immunochemical test for colorectal cancer screening.

  • Diagnostic testBreath sample acquisition for 13C Urea Breath Test

    13C Urea Breath test will be offered to participants at least 4 weeks after Helicobacter pylori eradication therapy end for eradication success control.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 30 days after test kit distribution, according to site-specific procedures.

  2. 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.

    Time frame: During the study recruitment period, up to 12 months.

  3. 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.

    Time frame: From positive SAT result through initiation of eradication therapy, up to 12 months

  4. 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.

    Time frame: At least 4 weeks after completion of eradication therapy, up to 12 months

  5. 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.

    Time frame: At the screening participation decision.

Secondary outcomes

  1. 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.

    Time frame: From initiation through completion of eradication therapy (10-14 days)

  2. 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.

    Time frame: Through study completion, an average of 1 year

  3. 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.

    Time frame: At initial screening assessment

  4. 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.

    Time frame: Through study completion, an average of 1 year

  5. 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.

    Time frame: Through study completion, an average of 1 year

  6. 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.

    Time frame: Through study completion, an average of 1 year

  7. 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.

    Time frame: Through study completion, an average of 1 year

  8. 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.

    Time frame: Through study completion, an average of 1 year

  9. 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.

    Time frame: Through study completion, an average of 1 year

  10. 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.

    Time frame: Through study completion, an average of 1 year

  11. 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.

    Time frame: At least 4 weeks after completion of eradication therapy, up to 12 months

  12. 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.

    Time frame: During eradication therapy (10-14 days).

  13. Upper gastrointestinal endoscopic findings

    Endoscopic findings among participants who undergo upper gastrointestinal endoscopy, summarized by finding category.

    Time frame: Through study completion, an average of 1 year

  14. Upper gastrointestinal histological findings

    Histological findings among participants with biopsy specimens obtained during upper gastrointestinal endoscopy, summarized by finding category.

    Time frame: Through study completion, an average of 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 24, 2026
  • Informed consent form · Jul 18, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.

Of 461 non-industry observational studies under Colorectal Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 132. This study's planned 12 months is below that.

Counting every sponsor, half of 562 studies reached it within 53 months; a quarter within 28 and three quarters within 103.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 24, 2026
First posted
Oct 14, 2026
StartEst.
Oct 2026
Primary completionEst.
Oct 2027
CompletionEst.
Mar 2028
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07873580
Lead sponsor
University of Latvia
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
First posted
Oct 14, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Mar 2028 (estimated)
Last update
Oct 14, 2026

Study contacts

Marcis Leja, Professor
Contact
marcis.leja@lu.lv
+37129497500
Kateryna Priadko, MD, PhD
Contact
kateryna.priadko@lu.lv
+393497555649
Marcis Leja, Professor
principal investigator · University of Latvia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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