Clinical trial · Observational
Prospective Gastric Cancer Screening With Fecal Multi-target DNA Analysis
A Prospective Study of Gastric Cancer Screening Based on Fecal Multi-Target DNA Analysis Combined With a Risk Questionnaire
- 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 evaluate the efficacy of a multi-target fecal DNA test for the early detection of gastric cancer. The test combines Helicobacter pylori gene detection with analysis of fecal methylated DNA markers. The primary objective is to assess whether each method, individually or in combination, can facilitate earlier diagnosis of gastric cancer. All participants will undergo the multi-target fecal DNA test and complete the gastric cancer risk questionnaire.
Conditions
Conditions (1)
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 (Stomach) Cancer | Childhood Gastric Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sensitivity and specificity of the fecal multi-target DNA test and questionnaire screening for gastric cancer
- timeFrame
- 2 years
- description
- To compare the sensitivity and specificity of the fecal multi-target DNA test and questionnaire screening for gastric cancer.
Secondary outcomes (4)
- measure
- Positive and negative predictive values of the fecal multi-target DNA test and the questionnaire screening method
- timeFrame
- 2 years
- description
- To compare the positive and negative predictive values of the fecal multi-target DNA test and the questionnaire screening method
- measure
- Number needed to screen to identify one gastric cancer
- timeFrame
- 2 years
- description
- To calculate and compare the number of participants needed to screen to identify one case of gastric cancer using the fecal DNA test versus the questionnaire.
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