Gastric cancer screening using stool H. pylori high-risk gene testing and a risk questionnaire

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational screening effort to recruit 10,000–15,000 residents from selected communities in Tongling City. Each participant provides a stool sample for fecal H. pylori gastric cancer susceptibility (SNP) testing and completes a face-to-face gastric cancer risk questionnaire after providing informed consent. Anyone who tests positive on the stool test or is identified as high-risk by the questionnaire is referred for confirmatory fiberoptic endoscopy and biopsy, and those not diagnosed in the first year enter annual follow-up. Residual fecal samples will be banked at Fudan University Shanghai Cancer Center for future biomarker research.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥40 years, male or female.
2. No contraindications to endoscopy and able to cooperate with endoscopy.
3. Patients must be able to fully understand the informed consent form and be able to sign the informed consent form in person.

Exclusion Criteria:

1. A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.
2. 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.
3. Severe mental illness or incapacity to participate in the study due to lack of civil behavior.
4. Pregnant or breastfeeding women.
5. Other conditions that the investigator deems inappropriate for participation in the study.

Where it's running

• People's Hospital of Tongling City
  Tongling, China Recruiting

Study contacts

• Study coordinator: Dazhi Xu, PhD
• Email: xudzh@fudan.edu.cn
• Phone: 86-18121299796

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.