NCT06943781

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15,000 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

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 fecal H. pylori gastric cancer susceptibility testing and complete a questionnaire. * Definition of Screening Positive: A participant will be considered screening positive if they test positive on the H. pylori gastric cancer susceptibility testing 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.

Conditions

• Gastric Adenocarcinoma
• Helicobacter Pylori

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Fecal Helicobacter pylori gastric cancer susceptibility gene test	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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-07-01
• Completion: 2027-12-31
• First posted: 2025-04-24
• Last updated: 2026-02-25

Locations

1 site across 1 country: China