A Prospective Study of Gastric Cancer Screening Based on Fecal Multi-Target DNA Analysis Combined With a Risk Questionnaire
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of the fecal multi-target DNA test and questionnaire screening for gastric cancer
研究概览
简要总结
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.
详细描述
Sample Selection:
The study will be conducted in selected communities within Tongling City, with a total of 10000-15000 residents recruited
Participants Recruitment:
- Participation is voluntary. All subjects must provide written informed consent at the time of recruitment.
- Well-trained investigators will conduct face-to-face interviews to administer the gastric cancer risk questionnaire.
Tests and Follow-up:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥40 years, male or female.
- •No contraindications to endoscopy and able to cooperate with endoscopy.
- •Patients must be able to fully understand the informed consent form and be able to sign the informed consent form in person.
排除标准
- •A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.
- •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.
- •Severe mental illness or incapacity to participate in the study due to lack of civil behavior.
- •Pregnant or breastfeeding women.
- •Other conditions that the investigator deems inappropriate for participation in the study.
结局指标
主要结局
Sensitivity and specificity of the fecal multi-target DNA test and questionnaire screening for gastric cancer
时间窗: 2 years
To compare the sensitivity and specificity of the fecal multi-target DNA test and questionnaire screening for gastric cancer.
次要结局
- Positive and negative predictive values of the fecal multi-target DNA test and the questionnaire screening method(2 years)
- Number needed to screen to identify one gastric cancer(2 years)
- Early diagnosis rate of gastric cancer(2 years)
- Diagnosis rate of precancerous lesions associated with gastric cancer(2 years)