Clinical trial NCT06943768: Fecal DNA Methylation and Helicobacter Pylori Gastric Cancer Susceptibility Genes Test
Official title: Fecal DNA Methylation and Helicobacter Pylori Gastric Cancer Susceptibility Genes for the Early Diagnosis and Screening of Gastric Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastric (Stomach) Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects for this clinical study were obtained from inpatients and outpatient follow-up patients attending the sub-center. Subjects will be identified by the investigator based on subject entry criteria and informed of the contents of the informed consent form. Subjects will have their feces collected at the time of clinic visit or at the time of physical examination and will be tested for fecal methylated DNA and H. pylori gastric cancer susceptibility genes.

Brief summary: 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.

Detailed description: Primary study objective: to evaluate the sensitivity and specificity of fecal methylation site-based and fecal Helicobacter pylori gastric cancer susceptibility gene assays applied to early diagnosis and screening of gastric cancer.

Secondary research objectives: 1. the accuracy, kappa value, area under the ROC curve, positive likelihood ratio, negative likelihood ratio, positive predictive value, and negative predictive value of fecal methylation site-based testing and fecal Helicobacter pylori gastric cancer susceptibility gene-based testing applied for predicting gastric cancer; 2. whether the predictive ability is significantly higher than that of conventional tumor markers, such as CA19-9, CEA, and CA72-4; and 3. the follow up of Gastritis and healthy people, to assess the cases of gastric cancer during the follow-up period and the clinical diagnosis and treatment prediction; 4. Follow-up gastric cancer patients, to assess the association with gastric cancer recurrence metastasis and treatment.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years, male or female.
* 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:

* 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.
* Those with unsatisfactory sample retention (e.g., too small a sample size)

Primary outcomes:
measure: Sensitivity and specificity
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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