RecruitingNCT06943781

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

Sponsor

Fudan University

Enrollment

15,000 participants

Start Date

Jul 1, 2025

Study Type

OBSERVATIONAL

Conditions

Gastric Adenocarcinoma Helicobacter Pylori

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

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This screening study is testing whether checking for specific genetic variants (SNPs) related to H. pylori infection — the stomach bacteria that causes most stomach cancers — can help identify people at higher risk of developing gastric (stomach) cancer earlier and more accurately. **You may be eligible if...** - You are 40 years of age or older - You have no contraindications to an endoscopy (a camera test of the stomach) - You are able to give informed consent in person **You may NOT be eligible if...** - You have a previous history of stomach cancer or other digestive tract cancers - You have severe underlying heart, lung, liver, or kidney disease that makes endoscopy unsafe or follow-up impractical - You have a severe mental illness preventing participation - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTFecal 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.

Locations(1)

People's Hospital of Tongling City

Tongling, China

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NCT06943781

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