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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,965
Diagnostic Test
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Cancer Hospital Affiliated to Shandong First Medical University (Shandong Institute of Cancer Prevention and Control, Shangdong Cancer Hospital)
Jinan, Shandong, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
Xi'an Daxing Hospital
Sensitivity for colorectal cancer with ColonAiQ test
The proportion of participants with colorectal cancer who have positive test results
Time frame: Up to 32 months
Specificity for colorectal cancer with ColonAiQ test
The proportion of negative test results among participants without CRC and other diseases
Time frame: Up to 32 months
PPV for colorectal cancer with ColonAiQ test
Positive Predictive Value: the proportion of positive test participants who are colorectal cancer patients.
Time frame: Up to 32 months
NPV for colorectal cancer with ColonAiQ test
Negative Predictive Value: the proportion of negative test participants who have no disease checked by colonoscopy.
Time frame: Up to 32 months
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Xi’an, Shanxi, China
Xi'an Gaoxin Hospital
Xi’an, Shanxi, China
Zhejiang provincial people's hospital
Hangzhou, Zhejiang, China
Fudan University Shanghai Cancer Center
Shanghai, China