Gastric (Stomach) CancerNCT06943794
Eradication of Helicobacter Pylori Subtypes at High Gastric Cancer Risk: a Cluster-randomized Controlled Trial
A study testing recommendations for Hp eradication treatment in people with Gastric (Stomach) Cancer, run by Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric (Stomach) Cancer
- What is being tested?
- recommendations for Hp eradication treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,824 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2026to 30 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years, gender is not limited.
- Voluntary participation with signed informed consent.
- No H. pylori eradication treatment received within the past 1 month.
- Able to complete stool sample collection and related examinations as per study requirements.
- Detected as high-risk by Hp subtype test.
Who cannot join
- A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.
- Comorbid severe underlying conditions (e.g., severe cardiopulmonary insufficiency, liver or renal failure, etc.) that are likely to result in a short life expectancy or render long-term follow-up impractical.
- Severe mental illness or incapacity to participate in the study due to lack of civil behavior.
- Pregnant or breastfeeding women.
- Other conditions that the investigator deems inappropriate for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
People's Hospital of Tongling City
Tongling
Guihe Wang, 86+05625838104, 2175613200@qq.com
About this study
Official title: Gastric Cancer Prevention Strategies Based on Eradication of Helicobacter Pylori Subtypes at High Risk for Gastric Cancer: a Practical Cluster-randomized Controlled Trial
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.
Read the detailed description
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:
- Intervention group: Received standardized H. pylori eradication treatment recommendations provided by trial staff/physicians based on patient risk, clinical symptoms, and other factors.
- Control group: Received standardized follow-up and routine management without treatment guidance for high-risk Hp subtypes.
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.
- Conditions
- Gastric (Stomach) Cancer
- Being tested
- recommendations for Hp eradication treatment
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recommendations for Hp eradication treatmentDrug
Also called Helicobacter pylori eradication
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)
- Omeprazole (or esomeprazole): 20mg, 2 times/day
- Bismuth citrate: 220mg, 2 times/day
- Metronidazole: 400mg, 3 times/day
- Tetracycline: 500mg, 3 times/day
- Treatment cycle: 10-14 days Eradication success was assessed after 1 month by urea breath test (UBT) or Hp fecal antigen test.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: recommendations for Hp eradication treatment |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 5 to 10 years
Secondary outcomes (3)
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.
Measured: Through study completion, an average of 5 to 10 years.
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.
Measured: 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.
Measured: Through study completion, an average of 5 to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start30 Mar 2026 (estimated)
- Primary completion1 May 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric (Stomach) CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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) 1. Omeprazole (or esomeprazole): 20mg, 2 times/day 2. Bismuth citrate: 220mg, 2 times/day 3. Metronidazole: 400mg, 3 times/day 4. Tetracycline: 500mg, 3 times/day 5. Treatment cycle: 10-14 days Eradication success was assessed after 1 month by urea breath test (UBT) or Hp fecal antigen test. Follow-up: Annual review of Hp infection status and assessment of the progression of gastric mucosal lesions.
- Masking
- None (open label)
- Enrolment
- 4,824 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dazhi Xu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943794
- Sponsor's protocol ID
- 2025RCT
- Status last verified
- Feb 2026
- First submitted
- 20 Mar 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Cancer Prevention Strategies Based on Eradication of Helicobacter Pylori Subtypes at High Risk for Gastric Cancer: a Practical Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06943794
- Acronym / sponsor ID
- 2025RCT
- Conditions
- Gastric (Stomach) Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,824 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Intervention group: Received standardized H. pylori eradication treatment recommendations provided by trial staff/physicians based on patient risk, clinical symptoms, and other factors.
- Control group: Received standardized follow-up and routine management without treatment guidance for high-risk Hp subtypes.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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) 1. Omeprazole (or esomeprazole): 20mg, 2 times/day 2. Bismuth citrate: 220mg, 2 times/day 3. Metronidazole: 400mg, 3 times/day 4. Tetracycline: 500mg, 3 times/day 5. Treatment cycle: 10-14 days Eradication success was assessed after 1 month by urea breath test (UBT) or Hp fecal antigen test. Follow-up: Annual review of Hp infection status and assessment of the progression of gastric mucosal lesions.
| Arm | Type | Receives |
|---|---|---|
| Treatment group (high-risk Hp subtype guidance + eradication treatment) | Experimental | Drug: recommendations for Hp eradication treatmentThe 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 40 years, gender is not limited.
- Voluntary participation with signed informed consent.
- No H. pylori eradication treatment received within the past 1 month.
- Able to complete stool sample collection and related examinations as per study requirements.
- Detected as high-risk by Hp subtype test.
Key exclusion criteria (5 listed)
- A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.
- Comorbid severe underlying conditions (e.g., severe cardiopulmonary insufficiency, liver or renal failure, etc.) that are likely to result in a short life expectancy or render long-term follow-up impractical.
- Severe mental illness or incapacity to participate in the study due to lack of civil behavior.
- Pregnant or breastfeeding women.
- Other conditions that the investigator deems inappropriate for participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recommendations for Hp eradication treatmentAlso: Helicobacter pylori eradicationA 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) 1. Omeprazole (or esomeprazole): 20mg, 2 times/day 2. Bismuth citrate: 220mg, 2 times/day 3. Metronidazole: 400mg, 3 times/day 4. Tetracycline: 500mg, 3 times/day 5. Treatment cycle: 10-14 days Eradication success was assessed after 1 month by urea breath test (UBT) or Hp fecal antigen test. | Drug | Treatment group (high-risk Hp subtype guidance + eradication treatment) |
Primary outcome
Five-year gastric cancer incidence in both groups
Time frame: Through study completion, an average of 5 to 10 years
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.
3 secondary outcomes
Ten-year gastric cancer incidence in both groups
Time frame: Through study completion, an average of 5 to 10 years.
Difference in early gastric cancer detection between the intervention group and the routine management group during follow-up
Time frame: Through study completion, an average of 5 to 10 years.
Difference in the detection of gastric precancerous lesions between the two groups
Time frame: Through study completion, an average of 5 to 10 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recommendations for Hp eradication treatment in people with Gastric (Stomach) Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dazhi Xu, Doctor (086-18121299796, xudzh@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Five-year gastric cancer incidence in both groups (time frame: Through study completion, an average of 5 to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.