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| Name | Class |
|---|---|
| Fudan University | OTHER |
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This was a case control, non-intervention study jointly developed by Fudan University Cancer Hospital and Shanghai Singlera Genomics Company. The enrolled population was screened by gastric surgery, including gastric cancer, precancerous lesions, benign lesions, and healthy control group. 10ml of whole blood of the enrolled subjects was collected for multi-target PCR detection of cfDNA methylation. The objective is to explore the clinical performance of polygene methylation (PCR-fluorescence probe) in the adjunctive diagnosis of gastric cancer, including the sensitivity of detection of various types and stages of gastric cancer, the specificity of detection of healthy controls, precancerous states, precancerous lesions, and the detection interference of other cancers. The diagnostic performance will be compared with CA199, CEA and CA724. The research data will provide a basis for screening targets for the development of detection kits.
Design and plan of the project: 1) Using the MONOD patent detection data of the company's previous research and combining with literature retrieval, analyze the tissue samples of gastric cancer of different stages and their paired paracancer tissues to screen the methylation mutation sites related to early gastric cancer and select the sites suitable for PCR detection; 2) ctDNA methylation markers in gastric cancer blood were preliminarily screened by plasma of healthy persons and preoperative plasma paired with tissues; 3) Using the screened blood ctDNA specific methylation markers, a targeted detection method for early gastric cancer lesions was designed; 4) The detection performance of the independent validation set sample confirmation establishment method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric cancer group | We anticipate enrolling approximately 620 gastric cancer (GC) cases, comprising 20 sets of GC tumors and their corresponding peritumoral tissue samples, as well as a minimum of 600 plasma samples from patients across stages I to IV of GC. Pathological diagnosis is required. |
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| Negative group | A total of approximately 520 cases were included in the study, comprising 20 cases providing white blood cell samples from healthy individuals, and 500 patients diagnosed with gastric diseases other than gastric cancer (such as gastritis, atrophy, intestinal metaplasia, etc.), who provided plasma samples. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | In this non-intervention study, 10ml of whole blood of enrolled subjects was collected for multi-target PCR detection of cfDNA methylation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of methylation detection in gastric cancer | To investigate the sensitivity and specificity of polygene methylation in the diagnosis of gastric cancer of different types and stages, and to evaluate its value as an auxiliary diagnosis. | assessed up to 12 months |
| Comparison of polygene methylation detection and other serological detection methods in gastric cancer | The specificity and sensitivity of multigene methylation (PCR-fluorescence probe) and CA199, CEA and CA724 in the auxiliary diagnosis of gastric cancer were compared. | assessed up to 12 months |
| Screening of genetic targets for kit development | The research data will provide a basis for screening gene targets for the development of subsequent detection kits. | assessed up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Eligible participants were recruited from the Department of Gastrosurgery, Fudan University Cancer Hospital, including gastric cancer, precancerous lesions of gastric cancer, other gastric lesions, no abnormalities in gastroscopy, and other cancers.
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| Name | Affiliation | Role |
|---|---|---|
| Rui Liu, PhD | Singlera Genomics Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Cancer Hospital | Shanghai | Shanghai Municipality | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31058531 | Background | Yu G, Wang GX, Wang HG, Mo FF, Tang BB. The value of detecting pepsinogen and gastrin-17 levels in serum for pre-cancerous lesion screening in gastric cancer. Neoplasma. 2019 Jul 23;66(4):637-640. doi: 10.4149/neo_2018_180825N647. Epub 2019 Apr 24. | |
| 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. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 32694610 | Background | Chen X, Gole J, Gore A, He Q, Lu M, Min J, Yuan Z, Yang X, Jiang Y, Zhang T, Suo C, Li X, Cheng L, Zhang Z, Niu H, Li Z, Xie Z, Shi H, Zhang X, Fan M, Wang X, Yang Y, Dang J, McConnell C, Zhang J, Wang J, Yu S, Ye W, Gao Y, Zhang K, Liu R, Jin L. Non-invasive early detection of cancer four years before conventional diagnosis using a blood test. Nat Commun. 2020 Jul 21;11(1):3475. doi: 10.1038/s41467-020-17316-z. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |