Clinical trial · Observational
Prospective Gastric Cancer Screening Using Helicobacter Pylori High-Risk Single Nucleotide Polymorphism Detection
Research on the Application of Fecal Helicobacter Pylori High-Risk Single Nucleotide Polymorphism Detection in the Early Diagnosis and Screening of Gastric Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective study designed to compare the performance of fecal H. pylori gastric cancer susceptibility analysis and the gastric cancer risk questionnaire for the early detection of gastric cancer. The primary objective is to assess whether each method, individually or in combination, can facilitate earlier diagnosis of gastric cancer. All participants will undergo fecal H. pylori gastric cancer susceptibility testing and complete the gastric cancer risk questionnaire.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Helicobacter Pylori | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fecal Helicobacter pylori gastric cancer susceptibility gene test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sensitivity and specificity of fecal H. pylori gastric cancer susceptibility testing and questionnaire for gastric cancer
- timeFrame
- 2 years
- description
- To compare the sensitivity and specificity of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening for gastric cancer.
Secondary outcomes (3)
- measure
- Positive and negative predictive values of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening for gastric cancer
- timeFrame
- 2 years
- description
- To compare the positive and negative predictive values of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening methods for gastric cancer
- measure
- Number needed to screen to identify one gastric cancer
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥40 years, male or female. 2. No contraindications to endoscopy and able to cooperate with endoscopy. 3. 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. A history of diagnosed gastric cancer or other malignant tumors of the digestive tract. 2. Comorbid severe underlying conditions (e.g., severe cardiopulmonary insufficiency, liver or renal failure, etc.) that are likely to result in a short life expectancy or render long-term follow-up impractical. 3. Severe mental illness or incapacity to participate in the study due to lack of civil behavior. 4. Pregnant or breastfeeding women. 5. Other conditions that the investigator deems inappropriate for participation in the study.
References
Publications (0)
Data not yet available