NCT07312500

Fecal DNA Methylation and Helicobacter Pylori SNPs Tests for Gastric Cancer

Application of Fecal DNA Methylation and Fecal Helicobacter Pylori Gastric Cancer Susceptibility Genes in Clinical Diagnosis, Treatment, and Relapse and Metastasis of Gastric Cancer

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Based on the detection technology of methylation sites in feces, combined or not combined with Helicobacter pylori gastric cancer susceptibility gene detection, an early diagnosis and detection system for gastric cancer is established, and the clinical diagnostic value of the detection system is evaluated. In addition, the study observed the association between different loci and post-treatment recurrence, metastasis, or long-term survival rate through long-term follow-up of gastric cancer patients; Follow up with individuals with benign diseases such as gastritis and healthy individuals, compare cases of gastric cancer, and compare their sample data during follow-up with controls who did not have the disease.

Conditions

• Gastric (Stomach) Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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: 2025-01-01
• Primary completion: 2027-10-01
• Completion: 2027-12-30
• First posted: 2025-12-31
• Last updated: 2025-12-31

Locations

1 site across 1 country: China