Fecal Helicobacter Pylori Gene Detection for Gastric Cancer

NCT ID: NCT06943781

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 13700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-12-31

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.

Conditions

Gastric Adenocarcinoma; Helicobacter Pylori

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Fecal Helicobacter pylori gastric cancer susceptibility gene test

In the early stage of the study, the team used genome-wide association analysis (GWAS) to identify H. pylori specific SNP that are significantly associated with gastric cancer in gastric cancer patients and controls; according to the mutation or not of the SNP loci, the strains were categorized into the high-risk group of gastric cancer (mutated group) and the low-risk group (un-mutated group). The mutation status of the SNP locus was detected in portable and non-invasive fecal samples from patients using molecular biology assays for early non-invasive screening and risk assessment of gastric cancer in H. pylori infected patients.

Intervention Type: DIAGNOSTIC_TEST

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).

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Dazhi Xu

Director of the gastric surgery department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2410-Exp081

Identifier Type: -

Identifier Source: org_study_id