Fecal DNA Methylation and Helicobacter Pylori Gastric Cancer Susceptibility Genes Test

NCT ID: NCT06943768

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 9654 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-06-30

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years old, male or female not limited.
• Within 90 days, the gastroscopy and/or pathological results confirm the absence of gastric cancer.
• Patients must be able to fully understand the informed consent form and be able to personally sign it.

Exclusion Criteria

• Severe cardiac, hepatic, or renal insufficiency, or psychiatric disorders.
• A previous history of malignant tumors of the upper gastrointestinal tract.
• Women during pregnancy.
• Those with undefined pathology.
• Those with unsatisfactory sample retention (e.g., too small a sample size)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Dazhi Xu

Director of the gastric surgery department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2410-Exp092

Identifier Type: -

Identifier Source: org_study_id