Clinical Validation of ColonAiQ (a Blood-based Assay Targeting ctDNA Methylation) for Colorectal Cancer Detection

Inclusion Criteria:

1. Age ≥18 years old, gender is not limited;
2. 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:

   1. Confirmed non-CRC digestive tract cases: colorectal polyps, adenomas, and other benign diseases of the digestive system;
   2. Confirmed cases of other cancers other than CRC: gastric, esophageal, breast, and lung cancer;
   3. diseases where the same gene methylation may be present (non-rheumatoid arthritis, etc.);
3. 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.

Exclusion Criteria:

1. People who cannot tolerate relevant tests for clinical diagnosis;
2. Pregnant women;
3. Patients who have previously received colorectal cancer surgery, tumor drug therapy, neoadjuvant therapy, or radiotherapy;
4. Other conditions deemed unsuitable for inclusion by the investigator.