Fecal DNA Methylation and Helicobacter Pylori Gastric Cancer Susceptibility Genes Test
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: fecal methylation site-based testing and fecal Helicobacter pylori gastric cancer susceptibility gene-based testing.
- Who it may be relevant to
- Registry conditions: Gastric (Stomach) Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Fecal DNA Methylation and Helicobacter Pylori Gastric Cancer Susceptibility Genes for the Early Diagnosis and Screening of Gastric Cancer
Overview
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 test 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.
Primary outcome measures
- Sensitivity and specificity [Time frame: Baseline]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06943768 · 2410-Exp092