Evaluation of the Serum Metabolite Based PrecogColo Dx Test for Advanced Colorectal Neoplasia Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 6
- 主要终点
- Primary Effectiveness Evaluations
研究概览
简要总结
This study is to Evaluate the diagnostic sensitivity of the serum metabolite based PrecogColo Dx test for advanced colorectal neoplasia Screening, including advanced adenoma and colorectal cancer. There are two steps in this study. Firstly, the diagnostic model is established based on tumor-specific and gut-microbiome related serum metabolites. Secondly, the sensitivity, specificity and accuracy of the diagnostic model is evaluated in detecting advanced adenoma and colorectal cancer stages in an independent multi-centered cohort.
详细描述
Subjects aged >45 at average risk for development of CRC will be enrolled. Subjects will complete the PrecogColo Dx test, followed by completion of a screening colonoscopy. . Results from PrecogColo Dx test were compared to the results of an optical colonoscopic examination, and histopathological diagnosis of all significant lesions discovered during the colonoscopy, in order to determine the sensitivity for CRC and advanced adenoma, respectively, as well as determining specificity of non-advanced neoplasia individuals. Histopathological results from biopsied tissue or excised lesions were categorized based on the most clinically significant lesion present by a central pathologist.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥ 45 years of age at the time of enrollment.
- •Subject presents for a screening colonoscopy.
- •Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
- •Subject is able and willing to sign informed consent.
排除标准
- •Patients received tumor treatment prior to the drawn of blood sample, including surgical resection, neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy and targeted therapy.
- •Patients received antibiotics within 2 weeks.
- •Patients with indications of emergency surgery, including bleeding, obstruction and perforation.
- •Patients who are positive for Human Immunodeficiency Virus (HIV).
- •Patients with abnormal liver and kidney function.
- •Patients with the history of inflammatory bowel disease.
- •Patients who had history of other malignancies.
- •Subject has a diagnosis or medical history of any of the following conditions:
- •Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome)
- •Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome")
结局指标
主要结局
Primary Effectiveness Evaluations
时间窗: 2 weeks
Lower bound of the 95% one-sided confidence interval of PrecogColo Dx Sensitivity for CRC was greater than 65%, and lower bound of the 95% one-sided confidence interval of PrecogColo Dx specificity for non-advanced neoplasia (including normal, non-adenomas polyps and low risk adenoma) was greater than 85%.
次要结局
未报告次要终点