Study on the Diagnostic Value of Multi-omics Combined Detection for Precancerous Lesions of Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Detection of advanced colorectal adenoma
研究概览
简要总结
Colorectal cancer (CRC) has become one of the most common malignant tumors in the world, and the key to its prevention and control is early detection and treatment. As colorectal adenoma and inflammatory bowel disease (IBD) are the inevitable precursors of most CRC, screening for colorectal adenoma and IBD is of great importance for preventing CRC. The existing detection methods have high sensitivity for CRC, while limited in colorectal adenoma and IBD. Therefore, exploring a detection method with high sensitivity for colorectal adenoma and IBD is necessary. This project intends to use methylation detection technology, lactic acid modified omics, proteomics, metagenomics, and other omics technology, through the analysis of differences in feces and histological results in healthy volunteers, patients with non-advanced adenoma, patients with advanced adenomas, patients with IBD, and patients with CRC for early screening.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients whose age is between 18-
- •Patients who have signed informed consent form.
排除标准
- •Patients who have undergone colonic resection or polypectomy.
- •Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days.
- •Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis).
- •Patients with pregnancy, severe chronic cardiopulmonary and renal disease.
- •Patients with failed cecal intubation.
- •Patients with poor BPQ necessitated a second bowel preparation.
- •Patients refusing to participate or to provide informed consent
结局指标
主要结局
Detection of advanced colorectal adenoma
时间窗: Through study completion, an average of 1 year
An advanced colorectal adenoma is defined as a colorectal adenoma ≥10 mm, adenoma with tubulovillous or villous histology, or adenoma with high-grade dysplasia
次要结局
- Detection of colorectal cancer(Through study completion, an average of 1 year)
- Detection of non-advanced colorectal adenoma(Through study completion, an average of 1 year)
研究者
Zhaoshen Li
Director of Gastroenterology Dept
Changhai Hospital