Clinical Validation of ColonAiQ (a Blood-based Assay Targeting Circulating Tumor DNA Methylation) for Colorectal Cancer Detection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,965
- 试验地点
- 7
- 主要终点
- Sensitivity for colorectal cancer with ColonAiQ test
研究概览
简要总结
The DNA methylation targets in preoperative plasma samples of the subjects will be detected by the multi-gene methylation test (ColonAiQ), and the test accuracy will be evaluated by compared with the clinical diagnosis evidence.
详细描述
The accuracy of ColonAiQ test in clinical testing will be evaluated in the multicenter, prospective study. Patients with colorectal cancer, intestinal polyps, adenomas and other non-neoplastic diseases of the digestive system, and patients with non-colorectal cancer such as gastric cancer, esophageal cancer, breast cancer and lung cancer will be enrolled. In this study, all cfDNA will be tested by fluorescence quantitative PCR, and some samples will be tested by NGS to verify the effectiveness of ColonAiQ test. Clinical diagnosis reports and methylation test results will be blinded to the lab tester and clinician respectively.
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
- •Age ≥18 years old, gender is not limited;
- •meet one of the following conditions: 1) Suspected colorectal cancer (CRC); 2) Diagnosed with CRC according to clinical diagnostic criteria; 3) Do not have CRC and have interfering diseases:
- •Confirmed non-CRC digestive tract cases: colorectal polyps, adenomas, and other benign diseases of the digestive system;
- •Confirmed cases of other cancers other than CRC: gastric, esophageal, breast, and lung cancer;
- •diseases where the same gene methylation may be present (non-rheumatoid arthritis, etc.);
- •The subject or his/her guardian is able to understand the purpose of the study, demonstrate sufficient adherence to the study protocol, and sign the informed consent.
排除标准
- •People who cannot tolerate relevant tests for clinical diagnosis;
- •Pregnant women;
- •Patients who have previously received colorectal cancer surgery, tumor drug therapy, neoadjuvant therapy, or radiotherapy;
- •Other conditions deemed unsuitable for inclusion by the investigator.
结局指标
主要结局
Sensitivity for colorectal cancer with ColonAiQ test
时间窗: Up to 32 months
The proportion of participants with colorectal cancer who have positive test results
Specificity for colorectal cancer with ColonAiQ test
时间窗: Up to 32 months
The proportion of negative test results among participants without CRC and other diseases
次要结局
- PPV for colorectal cancer with ColonAiQ test(Up to 32 months)
- NPV for colorectal cancer with ColonAiQ test(Up to 32 months)