Status:
NOT_YET_RECRUITING
An Observational Study for Gastric Cancer in Asymptomatic Carriers of High Risk Helicobacter Pylori
Lead Sponsor:
Fudan University
Conditions:
Gastric (Stomach) Cancer
Helicobacter Infection
Eligibility:
All Genders
18+ years
Brief Summary
This study is intended to be a prospective observational cohort study. The incidence of gastric cancer and progression of gastric precancerous lesions will be compared between groups through prospecti...
Detailed Description
Primary study objective: to assess the difference in the incidence of gastric cancer between asymptomatic carriers of high-risk SNP subtypes of H. pylori and the non-high-risk population during the fo...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old, gender is not limited;
- No previous history of gastric cancer (no radical surgery or radiotherapy treatment for gastric cancer);
- Able and willing to provide informed consent and willing to accept baseline and follow-up examinations;
- Able to cooperate in completing HP testing (breath test, gastroscopic biopsy or other standard testing methods) and HP SNP typing by stool testing;
- No obvious gastric symptoms at the time of initial screening, no progressive gastric cancer or serious gastric diseases (e.g., perforated acute ulcers, upper gastrointestinal hemorrhage, etc.) detected, and no need for urgent surgery (not planned within 3 months) or other therapeutic interventions for the time being.
Exclusion
- Diagnosed gastric cancer or other malignant tumors of the digestive tract;
- Comorbid serious underlying diseases (e.g., severe cardiopulmonary insufficiency, liver and renal failure, etc.) that are expected to have a short survival time or are not suitable for long-term follow-up;
- Inability to complete or refusal to undergo HP testing, SNP gene testing or follow-up;
- Presence of severe mental illness or incapacity for civil behavior that prevents completion of the study;
- Pregnant or breastfeeding women who are temporarily excluded;
- Other conditions that the investigator considers unsuitable for participation in this study.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2035
Estimated Enrollment :
6000 Patients enrolled
Trial Details
Trial ID
NCT06896370
Start Date
May 1 2025
End Date
December 31 2035
Last Update
March 26 2025
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