NCT06943768

Fecal DNA Methylation and Helicobacter Pylori Gastric Cancer Susceptibility Genes Test

Fecal DNA Methylation and Helicobacter Pylori Gastric Cancer Susceptibility Genes for the Early Diagnosis and Screening of Gastric Cancer

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 9,654 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter, cross-sectional study. It is based on fecal methylation site detection, H. pylori susceptibility testing of fecal samples, and a combination of the two, compared with the "gold standard" imaging tests, CT, gastroscopy and/or pathology, for gastric cancer, benign diseases such as gastritis, and health check-ups.

Detailed description

Primary study objective: to evaluate the sensitivity and specificity of fecal methylation site-based and fecal Helicobacter pylori gastric cancer susceptibility gene assays applied to early diagnosis and screening of gastric cancer. Secondary research objectives: 1. the accuracy, kappa value, area under the ROC curve, positive likelihood ratio, negative likelihood ratio, positive predictive value, and negative predictive value of fecal methylation site-based testing and fecal Helicobacter pylori gastric cancer susceptibility gene-based testing applied for predicting gastric cancer; 2. whether the predictive ability is significantly higher than that of conventional tumor markers, such as CA19-9, CEA, and CA72-4; and 3. the follow up of Gastritis and healthy people, to assess the cases of gastric cancer during the follow-up period and the clinical diagnosis and treatment prediction; 4. Follow-up gastric cancer patients, to assess the association with gastric cancer recurrence metastasis and treatment.

Conditions

• Gastric (Stomach) Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	fecal methylation site-based testing and fecal Helicobacter pylori gastric cancer susceptibility gene-based testing	To establish an early diagnostic test system for gastric cancer based on the methylation site detection technology in feces, with or without the combination of Helicobacter pylori gastric cancer susceptibility gene detection, and then to evaluate the clinical diagnostic value of this test system.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-04-30
• Completion: 2026-06-30
• First posted: 2025-04-24
• Last updated: 2025-06-24