Gastric (Stomach) Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTfecal 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.
Sponsors
Fudan University
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity | Baseline | 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. |
Outcome results
None listed