Colorectal Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTColonAiQ test and Colonoscopy
Diagnostic Test
Sponsors
Singlera Genomics Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity for colorectal cancer with ColonAiQ test | Up to 32 months | The proportion of participants with colorectal cancer who have positive test results |
| Specificity for colorectal cancer with ColonAiQ test | Up to 32 months | The proportion of negative test results among participants without CRC and other diseases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PPV for colorectal cancer with ColonAiQ test | Up to 32 months | Positive Predictive Value: the proportion of positive test participants who are colorectal cancer patients. |
| NPV for colorectal cancer with ColonAiQ test | Up to 32 months | Negative Predictive Value: the proportion of negative test participants who have no disease checked by colonoscopy. |
Countries
China
Outcome results
None listed