This is a prospective study designed to compare the performance of fecal H. pylori gastric cancer susceptibility analysis and the gastric cancer risk questionnaire for the early detection of gastric cancer. The primary objective is to assess whether each method, individually or in combination, can facilitate earlier diagnosis of gastric cancer. All participants will undergo fecal H. pylori gastric cancer susceptibility testing and complete the gastric cancer risk questionnaire.
Sample Selection: The study will be conducted in selected communities within Tongling City, with a total of 10000-15000 residents recruited. Participants Recruitment: * Participation is voluntary. All subjects must provide written informed consent at the time of recruitment. * Well-trained investigators will conduct face-to-face interviews to administer the gastric cancer risk questionnaire. Tests and Follow-up: * Initial Screening: All participants will provide a stool sample for fecal H. pylori gastric cancer susceptibility testing and complete a questionnaire. * Definition of Screening Positive: A participant will be considered screening positive if they test positive on the H. pylori gastric cancer susceptibility testing or are identified as high-risk through the questionnaire. * Diagnostic Workup: All screening-positive individuals will be referred for a confirmatory diagnostic workup. Briefly, the endoscopist will conduct a fiberoptic endoscopy and perform a pathological biopsy. * Follow-up: Screening-positive individuals who are not diagnosed with gastric cancer in the first year will be entered into an annual follow-up program. * Biobanking: Residual fecal samples will be stored at the biobank of Fudan University Shanghai Cancer Center for future biomarker research.
Study Type
OBSERVATIONAL
Enrollment
15,000
In the early stage of the study, the team used genome-wide association analysis (GWAS) to identify H. pylori specific SNP that are significantly associated with gastric cancer in gastric cancer patients and controls; according to the mutation or not of the SNP loci, the strains were categorized into the high-risk group of gastric cancer and the low-risk group. The status of the SNP locus was detected in portable and non-invasive fecal samples from participants using molecular biology assays for early non-invasive screening and risk assessment of gastric cancer in H. pylori infected patients.
People's Hospital of Tongling City
Tongling, China
RECRUITINGSensitivity and specificity of fecal H. pylori gastric cancer susceptibility testing and questionnaire for gastric cancer
To compare the sensitivity and specificity of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening for gastric cancer.
Time frame: 2 years
Positive and negative predictive values of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening for gastric cancer
To compare the positive and negative predictive values of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening methods for gastric cancer
Time frame: 2 years
Number needed to screen to identify one gastric cancer
To compare the number of participants needed to screen identify one gastric cancer for different methods
Time frame: 2 years
Early diagnosis rate of gastric cancer
To compare the early gastric cancer detection rate achieved by the fecal H. pylori gastric cancer susceptibility testing and the questionnaire screening.
Time frame: 2 years
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