Fecal Helicobacter Pylori Gene Detection for Gastric Cancer

Fudan University

Status: Begins enrollment this month

Conditions: Helicobacter Pylori; Gastric Adenocarcinoma

Treatments: Diagnostic Test: Fecal Helicobacter pylori gastric cancer susceptibility gene test

Study type: Observational

Funder types: Other

Identifiers

NCT06943781

2410-Exp081

Details and patient eligibility

About

This is a prospective, multicenter, cross-sectional study. The efficacy of fecal H. pylori gastric cancer susceptibility testing in predicting gastric cancer was evaluated by comparing fecal H. pylori gastric cancer susceptibility testing with the "gold standard" imaging tests, such as CT, gastroscopy, and/or pathology, in the enrolled population.

Full description

Primary study objective: to assess the sensitivity and specificity of fecal H. pylori gastric cancer susceptibility locus-based testing applied to predict gastric cancer.

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 H. pylori gastric cancer susceptibility locus test applied to predict gastric cancer; 2. whether the predictive ability is significantly higher than that of the conventional tumor markers, such as CA19-9, CEA, and CA72-4, etc.; and 3. combined with fecal methylation detection Predictive ability assessment.

The "fecal H. pylori-based gastric cancer susceptibility locus test" was compared with the "gold standard" CT, gastroscopy and/or pathology, and the results were analyzed for consistency.

Enrollment: 13,700 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Be ≥40 years of age, male or female.
2. Have or will have gastroscopy and/or pathology results.
3. Have no contraindications to endoscopy and be able to cooperate with endoscopy.
4. Patients must be able to fully understand the informed consent form and be able to sign the informed consent form in person.

Exclusion criteria

1. Severe cardiac, hepatic, or renal insufficiency, or psychiatric disorders.
2. A previous history of upper gastrointestinal malignancy.
3. Women during pregnancy.
4. Those whose pathology is not clear.
5. Those with unsatisfactory sample retention (e.g., too small a sample size).