Prospective Gastric Cancer Screening Using Helicobacter Pylori High-Risk Single Nucleotide Polymorphism Detection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorFudan University
About this trial
This is a prospective study designed to compare the performance of fecal H. pylori gastric cancer susceptibility analysis and the gastric cancer risk questionnaire for the early detection of gastric cancer. The primary objective is to assess whether each method, individually or in combination, can facilitate earlier diagnosis of gastric cancer. All participants will undergo fecal H. pylori gastric cancer susceptibility testing and complete the gastric cancer risk questionnaire.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥40 years, male or female.
No contraindications to endoscopy and able to cooperate with endoscopy.
Patients must be able to fully understand the informed consent form and be able to sign the informed consent form in person.
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 population
Subjects were recruited mainly from communities in Tongling, Anhui Province. The subjects were identified by the investigator based on the enrollment criteria and were informed about the contents of the informed consent form.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Fecal Helicobacter pylori gastric cancer susceptibility gene test
Diagnostic testIn the early stage of the study, the team used genome-wide association analysis (GWAS) to identify H. pylori specific SNP that are significantly associated with gastric cancer in gastric cancer patients and controls; according to the mutation or not of the SNP loci, the strains were categorized into the high-risk group of gastric cancer and the low-risk group. The status of the SNP locus was detected in portable and non-invasive fecal samples from participants using molecular biology assays for early non-invasive screening and risk assessment of gastric cancer in H. pylori infected patients.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Sensitivity and specificity of fecal H. pylori gastric cancer susceptibility testing and questionnaire for gastric cancer
To compare the sensitivity and specificity of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening for gastric cancer.
Time frame
2 yearsSecondary outcomes
1
Positive and negative predictive values of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening for gastric cancer
To compare the positive and negative predictive values of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening methods for gastric cancer
Time frame
2 years2
Number needed to screen to identify one gastric cancer
To compare the number of participants needed to screen identify one gastric cancer for different methods
Time frame
2 years3
Early diagnosis rate of gastric cancer
To compare the early gastric cancer detection rate achieved by the fecal H. pylori gastric cancer susceptibility testing and the questionnaire screening.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov