Application of Fecal DNA Methylation and Fecal Helicobacter Pylori Gastric Cancer Susceptibility Genes in Clinical Diagnosis, Treatment, and Relapse and Metastasis of Gastric Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Fudan University
- Enrollment
- 3,000
- Locations
- 1
- Primary Endpoint
- Positive predictive value of early diagnosis of gastric cancer
Study Overview
Brief Summary
Based on the detection technology of methylation sites in feces, combined or not combined with Helicobacter pylori gastric cancer susceptibility gene detection, an early diagnosis and detection system for gastric cancer is established, and the clinical diagnostic value of the detection system is evaluated. In addition, the study observed the association between different loci and post-treatment recurrence, metastasis, or long-term survival rate through long-term follow-up of gastric cancer patients; Follow up with individuals with benign diseases such as gastritis and healthy individuals, compare cases of gastric cancer, and compare their sample data during follow-up with controls who did not have the disease.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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 heart, liver, kidney dysfunction, or mental illness.
- •History of malignant tumors in the upper gastrointestinal tract.
- •Pregnant women.
- •Those with unclear pathology.
- •Those with unsatisfactory sample retention (such as insufficient sample size).
Outcomes
Primary Outcomes
Positive predictive value of early diagnosis of gastric cancer
Time Frame: baseline
Secondary Outcomes
No secondary outcomes reported
Investigators
Dazhi Xu
Director of the gastric surgery department
Fudan University