Multicenter prospective cohort study to identify high-risk group for primary gastric cancer using DNA methylation levels in normal-appearing gastric tissues in healthy people after Helicobacter pylori eradicatio
- Conditions
- Gastric cancer
- Registration Number
- JPRN-UMIN000016894
- Lead Sponsor
- Hoshi University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 1880
Not provided
1) Synchronous or metachronous (within 5 years) malignancies, except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2) Past history of gastrectomy, endoscopic treatment of a gastric tumor, and reconstructive surgery with a stomach tube for an esophageal cancer. 3) Past history of receiving chemotherapy (including endocrinotherapy) or radiation therapy against any other malignancies. 4) Suspicious gastric tumor by endoscopy or gastric biopsy at the time of eradication. 5) Psychosis. 6) Systemic steroid medication. 7) Individuals with two or more kinds of antiplatelet medications, with anticoagulant medication, or with coagulopathy. 8) Active gastrointestinal bleeding. 9) Individuals considered unsuitable for biopsy by an endoscopist. 10) Individuals with hereditary gastrointestinal tumors, including familial adenomatous polyposis (FAP), Lynch syndrome or Hereditary non-polyposis colorectal cancer (HNPCC), Peutz-Jeghers syndrome, Cowden syndrome, and Hereditary diffuse gastric cancer.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method disease-free survival
- Secondary Outcome Measures
Name Time Method - Incidence of primary gastric cancer and metachronous gastric cancer - Accuracy of prediction by DNA methylation markers (positive predictive value, negative predictive value, etc)