Fecal DNA Methylation and Helicobacter Pylori Gastric Cancer Susceptibility Genes Test

Fudan University

Status: Begins enrollment in 4 months

Conditions: Gastric (Stomach) Cancer

Treatments: Diagnostic Test: fecal methylation site-based testing and fecal Helicobacter pylori gastric cancer susceptibility gene-based testing

Study type: Observational

Funder types: Other

Identifiers

NCT06943768

2410-Exp092

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9,654 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)