Eradication of Helicobacter Pylori Subtypes at High Gastric Cancer Risk: a Cluster-randomized Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorFudan University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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) 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.

Treatment groups

4,824 Participants
are divided into 2 treatment groups
Group A: Treatment group (high-risk Hp subtype guidance + eradication treatment)Experimental treatment 1 intervention
Group B: Control group (routine Hp management)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Through study completion, an average of 5 to 10 years

Secondary outcomes

1

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.

Time frame
Through study completion, an average of 5 to 10 years.
2

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.

Time frame
Through study completion, an average of 5 to 10 years.
3

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.

Time frame
Through study completion, an average of 5 to 10 years.

Other outcomes

1

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.

Time frame
Through study completion, an average of 5 to 10 years

Sponsors and contacts

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