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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colorectal cancer group | Patients who are 18 years of age and older and diagnosed with colorectal cancer. |
| |
| Control group | Patients with 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, etc. as well as Individuals without any diseases checked by colonoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ColonAiQ test and Colonoscopy | Diagnostic Test | Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity for colorectal cancer with ColonAiQ test | The proportion of participants with colorectal cancer who have positive test results | Up to 32 months |
| Specificity for colorectal cancer with ColonAiQ test | The proportion of negative test results among participants without CRC and other diseases | Up to 32 months |
| Measure | Description | Time Frame |
|---|---|---|
| PPV for colorectal cancer with ColonAiQ test | Positive Predictive Value: the proportion of positive test participants who are colorectal cancer patients. | Up to 32 months |
| NPV for colorectal cancer with ColonAiQ test |
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Inclusion Criteria:
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:
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:
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Subjects 18 years of age and older who are eligible for colorectal cancer diagnosis and scheduled for a screening colonoscopy. more than 1000 subjects are targeted to enroll.
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| Name | Affiliation | Role |
|---|---|---|
| Guoxiang Cai, M.D. Ph.D. | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221000 | China | ||
| Cancer Hospital Affiliated to Shandong First Medical University (Shandong Institute of Cancer Prevention and Control, Shangdong Cancer Hospital) |
Individual participant data that underlie the results reported in publications of the study may be shared after de-identification.
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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Negative Predictive Value: the proportion of negative test participants who have no disease checked by colonoscopy.
| Up to 32 months |
| Jinan |
| Shandong |
| 250000 |
| China |
| Shanxi Provincial People's Hospital | Taiyuan | Shanxi | 030012 | China |
| Xi'an Daxing Hospital | Xi’an | Shanxi | 710000 | China |
| Xi'an Gaoxin Hospital | Xi’an | Shanxi | 710000 | China |
| Zhejiang provincial people's hospital | Hangzhou | Zhejiang | 310000 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |