Fecal DNA Methylation Detection for Gastric Cancer

Not yet recruiting

• Conditions: Gastric Adenocarcinoma

• Registration Number: NCT06943807
• Lead Sponsor: Fudan University

Brief Summary

The study is a prospective, multicentre, cross-sectional study to evaluate the efficacy of fecal methylation-based testing in comparison with the 'gold standard' imaging tests, such as CT, gastroscopy and/or pathology, for the prediction of gastric cancer in an enrolled population.

Detailed Description

Aims of the study Primary study aim: To assess the sensitivity and specificity of fecal methylation site-based tests for the prediction 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, negative predictive value of fecal methylation locus test for the prediction of gastric cancer; 2. whether the predictive ability is significantly higher than that of conventional tumour markers, such as CA19-9, CEA, and CA72-4, etc.; 3. The predictive ability of the combined fecal H. pylori gastric cancer susceptibility test was assessed.

Study design Prospective, multicentre, cross-sectional study. Study period 2 years from the start of the project as approved by the Institutional Ethics Committee.

Target population The target population is over 40 years old in areas with a high incidence of gastric cancer.

Sample size The sample size of this study should not be less than 10,800 cases.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-04-22
• Last Update Submitted: 2025-04-22
• Study First Posted: 2025-04-24
• Last Update Posted: 2025-04-24
• Study Start: 2025-05-01
• Primary Completion: 2026-05-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10800

Inclusion Criteria

• Age ≥40 years, male or female.
• Have or will have gastroscopy and/or pathology results.
• No contraindications to endoscopy and able to cooperate with endoscopy.
• Patients must be able to fully understand the informed consent form and be able to sign the informed consent form in person.

Exclusion Criteria

• Have severe cardiac, hepatic, or renal insufficiency, or mental disorders.
• Previous history of upper gastrointestinal malignancy.
• Women during pregnancy.
• Those with unspecified pathology.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of fecal DNA methylation testing based on its application for early diagnosis and screening of gastric cancer.	Baseline