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This study is a prospective, multicenter cluster randomized controlled trial. Additional fecal screening for high-risk SNP subtypes, in conjunction with routine Hp testing, may improve the identification of individuals at high risk for gastric cancer. Moreover, the implementation of eradication interventions in high-risk groups has the potential to significantly reduce the incidence and progression of gastric cancer.
Primary study objective: To compare the five-year gastric cancer incidence between the two groups during the follow-up period and assess the impact of the eradication strategy on the prevention of gastric cancer.
Secondary study objective: 1. To compare the ten-year gastric cancer incidence between the two groups during the follow-up period and further evaluate the long-term impact of the eradication strategy on the prevention of gastric cancer. 2. To compare the "high-risk SNP subtype eradication strategy" with routine Hp management in detecting early gastric cancer: Evaluate the difference in early gastric cancer detection between the intervention group and the routine management group during follow-up. 3. To compare the "high-risk SNP subtype eradication strategy" with routine Hp management in detecting gastric precancerous lesions: Assess the difference in the detection of gastric precancerous lesions between the two groups.
Other study objective: To evaluate the impact of the "high-risk Hp subtype eradication" strategy on treatment and management adherence.
Randomization: Subjects with high-risk subtypes who met the inclusion criteria were grouped into clusters and then randomized into an intervention group and a control group.
Intervention:
Follow-up and Comparison:
The follow-up will compare the differences between the two groups in terms of the detection rate of gastric cancer or precancerous lesions, the incidence (or progression) of gastric cancer, patient adherence, and complications within a specified follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group (high-risk Hp subtype guidance + eradication treatment) | Experimental | The guidance team, consisting of the attending physician and trial-related personnel, will conduct individualized assessments and education based on factors such as Hp infection, SNP results, gastric mucosa condition, and medical history, and provide eradication treatment recommendations. |
|
| Control group (routine Hp management) | No Intervention | According to the routine management of HP infected patients, symptomatic relief treatment will be provided, and no intervention guidance from the 'high-risk Hp subtype guidance group' will be given. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recommendations for Hp eradication treatment | Drug | A high-risk Hp subtype guidance group consisting of the receiving physician + trial-related personnel conducts individualized assessment based on Hp infection, SNP test results, gastric mucosa condition, medical history and other factors, and provides subjects with medical explanations and recommendations for eradication treatment. Eradication group protocol: standard quadruple therapy for H. pylori eradication program (PPI + bismuth + two antibiotics)
|
| Measure | Description | Time Frame |
|---|---|---|
| Five-year gastric cancer incidence in both groups | To compare the incidence of gastric cancer between the two groups during the follow-up period to assess the impact of the eradication strategy on the prevention of gastric cancer. | Through study completion, an average of 5 to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Ten-year gastric cancer incidence in both groups | To compare the incidence of gastric cancer between the two groups during the follow-up period to further evaluate the long-term impact of the eradication strategy on the prevention of gastric cancer. | Through study completion, an average of 5 to 10 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of the "high-risk Hp subtype eradication" strategy on treatment and management adherence | To evaluate how the eradication strategy affects adherence to treatment and management of Hp infection. | Through study completion, an average of 5 to 10 years |
Inclusion Criteria :
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dazhi Xu, Doctor | Contact | 086-18121299796 | xudzh@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Hospital of Tongling City | 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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Treatment group (high-risk Hp subtype guidance + eradication treatment):
A high-risk Hp subtype guidance group consisting of the receiving physician + trial-related personnel conducts individualized assessment based on Hp infection, SNP test results, gastric mucosa condition, medical history and other factors, and provides subjects with medical explanations and recommendations for eradication treatment.
Eradication group protocol: standard quadruple therapy for H. pylori eradication program (PPI + bismuth + two antibiotics)
Follow-up:
Annual review of Hp infection status and assessment of the progression of gastric mucosal lesions.
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|
|
| Difference in early gastric cancer detection between the intervention group and the routine management group during follow-up |
To comparison of the "high-risk SNP subtype eradication strategy" and routine Hp management in detecting early gastric cancer. |
| Through study completion, an average of 5 to 10 years. |
| Difference in the detection of gastric precancerous lesions between the two groups | To comparison of the "high-risk SNP subtype eradication strategy" and routine Hp management in detecting gastric precancerous lesions. | Through study completion, an average of 5 to 10 years. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |