Not Yet RecruitingNot Applicable

Eradication of Helicobacter Pylori Subtypes at High Gastric Cancer Risk: a Cluster-randomized Controlled Trial

China4,824 participantsStarted 2026-03-30

Plain-language summary

This study is a prospective, multicenter cluster randomized controlled trial. Additional fecal screening for high-risk SNP subtypes, in conjunction with routine Hp testing, may improve the identification of individuals at high risk for gastric cancer. Moreover, the implementation of eradication interventions in high-risk groups has the potential to significantly reduce the incidence and progression of gastric cancer.

Who can participate

Age range40 Years

SexALL

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Inclusion criteria

✓. Age ≥ 40 years, gender is not limited.
✓. Voluntary participation with signed informed consent.
✓. No H. pylori eradication treatment received within the past 1 month.
✓. Able to complete stool sample collection and related examinations as per study requirements.
✓. Detected as high-risk by Hp subtype test.

Exclusion criteria

✕. A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.
✕. Comorbid severe underlying conditions (e.g., severe cardiopulmonary insufficiency, liver or renal failure, etc.) that are likely to result in a short life expectancy or render long-term follow-up impractical.
✕. Severe mental illness or incapacity to participate in the study due to lack of civil behavior.
✕. Pregnant or breastfeeding women.
✕. Other conditions that the investigator deems inappropriate for participation in the study.

What they're measuring

Five-year gastric cancer incidence in both groups

Timeframe: Through study completion, an average of 5 to 10 years

Trial details

NCT IDNCT06943794

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-05-01

Contact for this trial

Dazhi Xu, Doctor

086-18121299796 xudzh@fudan.edu.cn

View on ClinicalTrials.gov More Gastric (Stomach) Cancer trials