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This is a prospective study designed to evaluate the efficacy of a multi-target fecal DNA test for the early detection of gastric cancer. The test combines Helicobacter pylori gene detection with analysis of fecal methylated DNA markers. The primary objective is to assess whether each method, individually or in combination, can facilitate earlier diagnosis of gastric cancer. All participants will undergo the multi-target fecal DNA test 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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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of the fecal multi-target DNA test and questionnaire screening for gastric cancer | To compare the sensitivity and specificity of the fecal multi-target DNA test and questionnaire screening for gastric cancer. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and negative predictive values of the fecal multi-target DNA test and the questionnaire screening method | To compare the positive and negative predictive values of the fecal multi-target DNA test and the questionnaire screening method | 2 years |
| Number needed to screen to identify one gastric cancer |
| Measure | Description | Time Frame |
|---|---|---|
| Development of a new screening strategy | To perform a comprehensive analysis of the performance of all methods and develop an optimized, evidence-based strategy for population-based gastric cancer screening. | 2 years |
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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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Feces
To calculate and compare the number of participants needed to screen to identify one case of gastric cancer using the fecal DNA test versus the questionnaire. |
| 2 years |
| Early diagnosis rate of gastric cancer | To compare the early gastric cancer detection rate achieved by the fecal multi-target DNA testing and the questionnaire. | 2 years |
| Diagnosis rate of precancerous lesions associated with gastric cancer | To compare the detection rate of the fecal multi-target DNA testing and the questionnaire for precancerous lesions associated with gastric cancer | 2 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |