Stool-based multi-target DNA screening for stomach cancer

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 prospective program will recruit about 10,000–15,000 residents from selected communities in Tongling City who are 40 years or older to provide a stool sample and complete a gastric cancer risk questionnaire. Screening positives—defined by a positive stool multi-target DNA test or a high-risk questionnaire—will be referred for diagnostic fiberoptic endoscopy and biopsy. Individuals not diagnosed with cancer in the first year will enter annual follow-up, and leftover stool specimens will be stored at the Fudan University Shanghai Cancer Center biobank for future biomarker research. The study compares H. pylori gene detection and fecal methylated DNA markers, alone and in combination, to see if they enable earlier gastric cancer diagnosis.

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.