Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
10800 participants
OBSERVATIONAL
2025-12-01
2026-12-30
Brief Summary
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Detailed Description
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Secondary research objectives: 1. the accuracy, kappa value, area under the ROC curve, positive likelihood ratio, negative likelihood ratio, positive predictive value, negative predictive value of fecal methylation locus test for the prediction of gastric cancer; 2. whether the predictive ability is significantly higher than that of conventional tumour markers, such as CA19-9, CEA, and CA72-4, etc.; 3. The predictive ability of the combined fecal H. pylori gastric cancer susceptibility test was assessed.
Study design Prospective, multicentre, cross-sectional study. Study period 2 years from the start of the project as approved by the Institutional Ethics Committee.
Target population The target population is over 40 years old in areas with a high incidence of gastric cancer.
Sample size The sample size of this study should not be less than 10,800 cases.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Fecal sample methylation detection for gastric cancer
Detection of gastric cancer-associated methylation sites in fecal samples
Eligibility Criteria
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Inclusion Criteria
* Have or will have gastroscopy and/or pathology results.
* 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.
Exclusion Criteria
* Previous history of upper gastrointestinal malignancy.
* Women during pregnancy.
* Those with unspecified pathology.
40 Years
ALL
Yes
Sponsors
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Fudan University
OTHER
Responsible Party
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Dazhi Xu
Director
Other Identifiers
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2014-Exp079
Identifier Type: -
Identifier Source: org_study_id
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