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NOT YET RECRUITING
NCT07873580

European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers

Sponsor: University of Latvia

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

OBSERVATIONAL

Enrollment

8000

Start Date

2026-10

Completion Date

2028-03

Last Updated

2026-10-14

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Fecal 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_TEST

Upper 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_TEST

Colonoscopy 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.

DRUG

Helicobacter 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_TEST

Fecal sample acquisition for Fecal Immunochemical test

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

DIAGNOSTIC_TEST

Breath 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.