Prospective Gastric Cancer Screening Using Helicobacter Pylori High-Risk Single Nucleotide Polymorphism Detection
Research on the Application of Fecal Helicobacter Pylori High-Risk Single Nucleotide Polymorphism Detection in the Early Diagnosis and Screening of Gastric Cancer
Fudan University
15,000 participants
Jul 1, 2025
OBSERVATIONAL
Conditions
Summary
This is a prospective study designed to compare the performance of fecal H. pylori gastric cancer susceptibility analysis and the gastric cancer risk questionnaire for the early detection of gastric cancer. The primary objective is to assess whether each method, individually or in combination, can facilitate earlier diagnosis of gastric cancer. All participants will undergo fecal H. pylori gastric cancer susceptibility testing and complete the gastric cancer risk questionnaire.
Eligibility
Inclusion Criteria3
- 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 Criteria5
- 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.
Interventions
In the early stage of the study, the team used genome-wide association analysis (GWAS) to identify H. pylori specific SNP that are significantly associated with gastric cancer in gastric cancer patients and controls; according to the mutation or not of the SNP loci, the strains were categorized into the high-risk group of gastric cancer and the low-risk group. The status of the SNP locus was detected in portable and non-invasive fecal samples from participants using molecular biology assays for early non-invasive screening and risk assessment of gastric cancer in H. pylori infected patients.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06943781