Fecal DNA Methylation and Helicobacter Pylori Gastric Cancer Susceptibility Genes Test

NCT06943768 | Not Yet Recruiting

• 1 other identifier: 2410-Exp092
• Study Type: observational
• Target: 9,654
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastric (Stomach) Cancer

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity

  Sensitivity and specificity of fecal DNA methylation detection and Helicobacter pylori gastric cancer susceptibility genes based on their application for early diagnosis and screening of gastric cancer.

  Baseline

Interventions

fecal methylation site-based testing and fecal Helicobacter pylori gastric cancer susceptibility gene-based testing DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The subjects of this clinical study are from the community population in the high incidence area of gastric cancer in Tongling. The subjects will collect feces during medical visits or physical examinations, and undergo fecal methylation DNA and Helicobacter pylori gastric cancer susceptibility gene testing. The researchers determine the study subjects based on the inclusion and exclusion criteria and inform them of the content of the informed consent form.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the gastric surgery department

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 24, 2025
• Study Start: December 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 24, 2025

Record last verified: 2024-11