Fecal DNA Methylation and Helicobacter Pylori Gastric Cancer Susceptibility Genes Test

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFudan University

About this trial

This is a multicenter, cross-sectional study. It is based on fecal methylation site detection, H. pylori susceptibility testing of fecal samples, and a combination of the two, compared with the "gold standard" imaging tests, CT, gastroscopy and/or pathology, for gastric cancer, benign diseases such as gastritis, and health check-ups.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 18 years old, male or female not limited.

Within 90 days, the gastroscopy and/or pathological results confirm the absence of gastric cancer.

Patients must be able to fully understand the informed consent form and be able to personally sign it.

Disqualifiers

Severe cardiac, hepatic, or renal insufficiency, or psychiatric disorders.

A previous history of malignant tumors of the upper gastrointestinal tract.

Women during pregnancy.

Those with undefined pathology.

Trial population

The subjects of this clinical study are from the community population in the high incidence area of gastric cancer in Tongling. The subjects will collect feces during medical visits or physical examinations, and undergo fecal methylation DNA and Helicobacter pylori gastric cancer susceptibility gene testing. The researchers determine the study subjects based on the inclusion and exclusion criteria and inform them of the content of the informed consent form.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • fecal methylation site-based testing and fecal Helicobacter pylori gastric cancer susceptibility gene-based testing

    Diagnostic test

    To establish an early diagnostic test system for gastric cancer based on the methylation site detection technology in feces, with or without the combination of Helicobacter pylori gastric cancer susceptibility gene detection, and then to evaluate the clinical diagnostic value of this test system.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Sensitivity and specificity

Sensitivity and specificity of fecal DNA methylation detection and Helicobacter pylori gastric cancer susceptibility genes based on their application for early diagnosis and screening of gastric cancer.

Time frame
Baseline

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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