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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:
Tests and Follow-up:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Helicobacter pylori gastric cancer susceptibility gene test | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects were recruited mainly from communities in Tongling, Anhui Province. The subjects were identified by the investigator based on the enrollment criteria and were informed about the contents of the informed consent form.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dazhi Xu, PhD | Contact | 86-18121299796 | xudzh@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Hospital of Tongling City | Recruiting | Tongling | China |
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Feces
| 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 |
| 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. | 2 years |