Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers: a Multi-center Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 13
- 主要终点
- Sensitivity and Specificity of Stool-Based Biomarker Testing for Gastrointestinal Cancer Screening
研究概览
简要总结
This study is a multi-center, observational study. Participants scheduled for gastroscopy and colonoscopy will undergo an epidemiological assessment and provide a stool sample prior to endoscopy for qualitative Fecal Immunochemical Test (FIT), quantitative Fecal Immunochemical Test (FIT), and novel biomarker testing, followed by the endoscopic examination. After completion of the baseline endoscopic screening, all enrolled participants will undergo a 2-year follow-up. The primary endpoints of the study are sensitivity and specificity for the screening of gastrointestinal cancers.The aim of this study is to develop and evaluate the sensitivity and specificity of fecal multi-marker panels for the screening of gastrointestinal cancers.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be at least 18 years of age at the time of enrollment;
- •Participants must be scheduled to undergo gastroscopy and colonoscopy;
- •Participants must agree to undergo a two-year follow-up as outlined in the protocol;
- •Participants must be willing to participate and sign an informed consent form.
排除标准
- •Have undergone gastrointestinal endoscopy screening within the past year;
- •History of any type of gastrointestinal malignancy;
- •Concurrent severe medical conditions that reduce the benefits of screening, such as severe pulmonary disease, kidney disease, liver disease, cardiovascular and cerebrovascular diseases, and hematological disorders;
- •Other situations where a physician determines that endoscopic screening poses excessive risk (e.g., hemodynamic instability) or offers no benefit (e.g., short life expectancy);
- •Pregnant or breastfeeding women.
结局指标
主要结局
Sensitivity and Specificity of Stool-Based Biomarker Testing for Gastrointestinal Cancer Screening
时间窗: At the time of baseline endoscopic screening, approximately 2 weeks after stool sample collection.
次要结局
未报告次要终点