Prospective Gastric Cancer Screening With Fecal Multi-target DNA Analysis
ConditionGastric (Stomach) Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorFudan University
About this trial
This is a prospective study designed to evaluate the efficacy of a multi-target fecal DNA test for the early detection of gastric cancer. The test combines Helicobacter pylori gene detection with analysis of fecal methylated DNA markers. The primary objective is to assess whether each method, individually or in combination, can facilitate earlier diagnosis of gastric cancer. All participants will undergo the multi-target fecal DNA test 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
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Sensitivity and specificity of the fecal multi-target DNA test and questionnaire screening for gastric cancer
To compare the sensitivity and specificity of the fecal multi-target DNA test and questionnaire screening for gastric cancer.
Time frame
2 yearsSecondary outcomes
1
Positive and negative predictive values of the fecal multi-target DNA test and the questionnaire screening method
To compare the positive and negative predictive values of the fecal multi-target DNA test and the questionnaire screening method
Time frame
2 years2
Number needed to screen to identify one gastric cancer
To calculate and compare the number of participants needed to screen to identify one case of gastric cancer using the fecal DNA test versus the questionnaire.
Time frame
2 years3
Early diagnosis rate of gastric cancer
To compare the early gastric cancer detection rate achieved by the fecal multi-target DNA testing and the questionnaire.
Time frame
2 years4
Diagnosis rate of precancerous lesions associated with gastric cancer
To compare the detection rate of the fecal multi-target DNA testing and the questionnaire for precancerous lesions associated with gastric cancer
Time frame
2 yearsOther outcomes
1
Development of a new screening strategy
To perform a comprehensive analysis of the performance of all methods and develop an optimized, evidence-based strategy for population-based gastric cancer screening.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov