Prospective Gastric Cancer Screening With Fecal Multi-target DNA Analysis

Sample Selection:

The study will be conducted in selected communities within Tongling City, with a total of 10000-15000 residents recruited

Participants Recruitment:

• Participation is voluntary. All subjects must provide written informed consent at the time of recruitment.
• Well-trained investigators will conduct face-to-face interviews to administer the gastric cancer risk questionnaire.

Tests and Follow-up:

• Initial Screening: All participants will provide a stool sample for the multi-target DNA analysis (including H. pylori susceptibility testing and methylated DNA markers) and complete a questionnaire.
• Definition of Screening Positive: A participant will be considered screening positive if they test positive on the fecal multi-target DNA test or are identified as high-risk through the questionnaire.
• Diagnostic Workup: All screening-positive individuals will be referred for a confirmatory diagnostic workup. Briefly, the endoscopist will conduct a fiberoptic endoscopy and perform a pathological biopsy.
• Follow-up: Screening-positive individuals who are not diagnosed with gastric cancer in the first year will be entered into an annual follow-up program.
• Biobanking: Residual fecal samples will be stored at the biobank of Fudan University Shanghai Cancer Center for future biomarker research.

Inclusion criteria

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

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.