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| Name | Class |
|---|---|
| Northern Jiangsu People's Hospital | OTHER |
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This is a cross-sectional cohort study based on community population jointly developed by Northern Jiangsu People's Hospital and Shanghai Kunyuan Biological Technology Co., LTD. This study will verify the real world results of polygene methylation detection of colorectal cancer in a large prospective cohort of community population, which is expected to enroll 80,000 permanent residents in Yangzhou city. The preliminary design period of the study is 5 years. In this study, questionnaire survey and polygene methylation test of colorectal cancer were used as the primary screening method, and colonoscopy was used as the further validation examination method to screen colorectal cancer and precancerous lesions. The diagnosis and outcome of all lesions were based on colonoscopy and pathological examination. The evaluation indexes include sensitivity, specificity, detection rate of precancerous lesions and adenoma.
The study is expected to complete baseline examinations of 80,000 subjects within 1 year. Community members who sign informed consent forms will complete the Colorectal cancer Risk Factor Assessment Questionnaire, history collection, and colorectal cancer polymethylation test early screening at baseline. Subjects who tested positive for polygene methylation screening for colorectal cancer will undergo a fecal immunochemistry (FIT) test, a blood carcinoembryo antigen (CEA) test, and colonoscopy within 3 months. Telephone follow-up medical history was collected at 1, 2, 3, and 4 years after baseline, and telephone follow-up survival outcomes were studied at 5 years after baseline. During the follow-up, patients diagnosed with colorectal cancer by colonoscopy will reach the study end point, and patients treated with polyps or adenomas found during colonoscopy will also reach the study end point.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive group | subjects received colorectal cancer polygene methylation test at baseline, and all positive results were included in the positive group. They will undergo further FIT testing, blood carcinoembryonic antigen testing and colonoscopy within three months of colorectal cancer polymethylation testing. |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of polygenic methylation detection in colorectal cancer | To evaluate the sensitivity, specificity, and positive/negative predictive value of polygenic methylation tests for colorectal cancer in subjects | assessed up to 5 years |
| Application value of polygene methylation detection in colorectal cancer in community population | To verify the effectiveness and clinical value of this detection method in the diagnosis of colorectal cancer in yangzhou community population. | assessed up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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The subjects of this study were permanent residents in Yangzhou who met the inclusion criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Jun, Master | Contact | 18051061318 | sbyy_liujun@163.com | |
| Liu Rui, Doctor | Contact | rliu@singleragenomics.com |
| Name | Affiliation | Role |
|---|---|---|
| Liu Jun, Master | Northern Jiangsu People's Hospital,Yangzhou,China | Study Director |
| Liu Rui, Doctor | Singlera Genomics Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Jiangsu People's Hospital | Recruiting | Yangzhou | Jiangsu | 201299 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28263317 | Background | Guo S, Diep D, Plongthongkum N, Fung HL, Zhang K, Zhang K. Identification of methylation haplotype blocks aids in deconvolution of heterogeneous tissue samples and tumor tissue-of-origin mapping from plasma DNA. Nat Genet. 2017 Apr;49(4):635-642. doi: 10.1038/ng.3805. Epub 2017 Mar 6. | |
| 39604913 | Derived | Wang B, Zhang Y, Liu J, Deng B, Li Q, Liu H, Sui Y, Wang N, Xiao Q, Liu W, Chen Y, Li Y, Jia H, Yuan Q, Wang C, Pan W, Li F, Yang H, Wang Y, Ding Y, Xu D, Liu R, Fang JY, Wu J. Colorectal cancer screening using a multi-locus blood-based assay targeting circulating tumor DNA methylation: a cross-sectional study in an average-risk population. BMC Med. 2024 Nov 27;22(1):560. doi: 10.1186/s12916-024-03777-2. |
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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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| Yangzhou First People's Hospital | Recruiting | Yangzhou | Jiangsu | 225007 | China |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |