Fecal Helicobacter Pylori Gene Detection for Gastric Cancer

Not yet recruiting

• Conditions: Gastric Adenocarcinoma; Helicobacter Pylori

• Registration Number: NCT06943781
• Lead Sponsor: Fudan University

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-04-22
• Last Update Submitted: 2025-04-22
• Study First Posted: 2025-04-24
• Last Update Posted: 2025-04-24
• Study Start: 2025-06-01
• Primary Completion: 2027-04-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 13700

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
completed all phases of the study	Baseline	The endpoint of the study will be reached if the participant has completed all phases of the study according to the study protocol (i.e., has completed sample collection, testing, and obtained "gold standard" gastroscopy and/or pathology results) or has withdrawn informed consent.