RecruitingNot Applicable

Prospective Gastric Cancer Screening With Fecal Multi-target DNA Analysis

China15,000 participantsStarted 2025-07-01

Plain-language summary

This is a prospective study designed to evaluate the efficacy of a multi-target fecal DNA test for the early detection of gastric cancer. The test combines Helicobacter pylori gene detection with analysis of fecal methylated DNA markers. The primary objective is to assess whether each method, individually or in combination, can facilitate earlier diagnosis of gastric cancer. All participants will undergo the multi-target fecal DNA test and complete the gastric cancer risk questionnaire.

Who can participate

Age range40 Years

SexALL

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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.

What they're measuring

Sensitivity and specificity of the fecal multi-target DNA test and questionnaire screening for gastric cancer

Timeframe: 2 years

Trial details

NCT IDNCT06943807

SponsorFudan University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-30

Contact for this trial

Dazhi Xu, PhD

86-18121299796 xudzh@fudan.edu.cn

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