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Prospective Gastric Cancer Screening Using Helicobacter Pylori High-Risk Single Nucleotide Polymorphism Detection

NCT06943781 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 15000

Last updated 2026-02-25

No results posted yet for this study

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.

Conditions

  • Gastric Adenocarcinoma
  • Helicobacter Pylori

Interventions

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2027-07-01
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06943781 on ClinicalTrials.gov