Clinical trial NCT06943781: Fecal Helicobacter Pylori Gene Detection for Gastric Cancer
Official title: Research on the Application of Fecal Helicobacter Pylori Gastric Cancer Susceptibility Gene Detection in Early Diagnosis and Screening of Gastric Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastric Adenocarcinoma
Helicobacter Pylori
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 13700
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects for this clinical study were obtained from inpatients and outpatient follow-up patients attending the sub-centers. Subjects will be identified by the investigator based on the subject enrollment criteria and informed of the contents of the informed consent form.

Subjects participating in the Early Diagnosis and Early Screening of Gastric Cancer study will have feces collected at the time of clinic visit or at the time of physical examination and will undergo fecal H. pylori gastric cancer susceptibility gene testing.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: completed all phases of the study
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: