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| Name | Class |
|---|---|
| Huashan Hospital | OTHER |
| Zhejiang University | OTHER |
| West China Hospital | OTHER |
| The First Hospital of Jilin University |
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The purpose of this trail is to evaluate the performance of Genetron IDH1 PCR Kit in Glioma patients using real-time PCR method.
This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron IDH1 PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method. Combined with the results of clinicopathological classification, the incidence of IDH1 gene R132H mutation in different subtypes was counted to evaluate the clinical performance of the Genetron IDH1 PCR Kit.
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the Genetron IDH1 PCR Kit | The main purpose of this study is: by evaluating the Genetron IDH1 PCR Kit to compare the results of the Sanger sequencing method, and to calculate the coincidence rate and consistency of the two methods. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Hospital sample
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Jilin City | China | ||||
| Huashan Hospital of Fudan University |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2016 | Nov 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| OTHER |
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| Shanghai |
| China |
| West China Hospital of Sichuan University | Sichuan | China |
| The Second Affiliated Hospital of Zhejiang University | Zhejiang | China |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |