Actively Recruiting
Research on the Application of Fecal Helicobacter Pylori High-Risk Single Nucleotide Polymorphism Detection in the Early Diagnosis and Screening of Gastric Cancer
Led by Fudan University · Updated on 2026-02-25
15000
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective study to compare two methods for early detection of gastric cancer: fecal Helicobacter pylori gastric cancer susceptibility testing and a gastric cancer risk questionnaire. The goal is to see if either method alone or combined can help diagnose gastric cancer earlier. This study involves adults aged 40 years and older from selected communities in Tongling City. Participants will provide stool samples for molecular testing to detect specific genetic markers linked to gastric cancer risk from H. pylori infection. They will also complete a detailed questionnaire about their gastric cancer risk. Those who test positive on either method will be referred for confirmatory diagnostic procedures, including fiberoptic endoscopy and biopsy. Individuals without a cancer diagnosis in the first year will enter an annual follow-up program. Residual stool samples will be stored for future biomarker research. Throughout the study, participants will undergo screening and risk assessment, followed by diagnostic workups if indicated. Researchers will monitor the accuracy of the testing methods over two years, measuring sensitivity, specificity, predictive values, and the rate of early gastric cancer diagnosis. The study will track participants' health and collect data to evaluate how well these tools identify gastric cancer early, aiming to improve detection strategies.
CONDITIONS
Brief Title
Prospective Gastric Cancer Screening Using Helicobacter Pylori High-Risk Single Nucleotide Polymorphism Detection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older, any gender
- No contraindications to endoscopy and able to cooperate with endoscopy
- Able to understand and sign the informed consent form in person
You will not qualify if you...
- History of diagnosed gastric cancer or other malignant tumors of the digestive tract
- Severe underlying conditions such as cardiopulmonary insufficiency, liver or renal failure likely to limit life expectancy or follow-up
- Severe mental illness or inability to participate due to lack of civil behavior
- Pregnant or breastfeeding women
- Any condition deemed inappropriate for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to provide a stool sample and complete a questionnaire
Duration - Up to 1 year for initial diagnosis
Participants who test positive on the screening or are identified as high-risk will undergo confirmatory diagnostic procedures including fiberoptic endoscopy and pathological biopsy.
1 to 2 visits for endoscopy and biopsy
Duration - Annual follow-up for up to 2 years
Participants who are screening positive but not diagnosed with gastric cancer in the first year will be followed annually for ongoing monitoring.
Annual visits for up to 2 years
Trial Site Locations
Total: 1 location
1
People's Hospital of Tongling City
Tongling, China
Actively Recruiting
Research Team
D
Dazhi Xu, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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