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| Name | Class |
|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
| The Second Affiliated Hospital Zhejiang University School of Medcine | UNKNOWN |
| Henan Cancer Hospital | OTHER_GOV |
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The purpose of this trail is to evaluate the performance of Genetron lung cancer panel in non-small cell lung cancer patients using semiconductor sequencing method.
This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron lung cancer panel and comparison methods. The detection results are compared, and the samples that are inconsistent with the detection results of similar products on the market are reviewed by the the Sanger sequencing method, when the site detection results compared with Sanger sequencing method are inconsistent, Sanger's detection results are recognized. The safety and effectiveness of this panel are confirmed and evaluated. Meanwhile, the accuracy of this panel for the following drug companion diagnostic tests: EGFR gene 19 exon deletion and L858R point mutation in gefitinib tablets, erlotinib hydrochloride and icotinib hydrochloride tablets, T790M point mutation in methanesulfonate acid osimertinib tablets, ALK gene fusion in crizotinib capsules.
The results were determined independently according to the cutoff values or interpretation requirements provided by each method, and relevant statistics were used to evaluate clinical application performance of Genetron lung cancer panel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinically diagnosed as non-small cell lung cancer samples |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genetron lung cancer panel | Diagnostic Test | Follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron lung cancer panel and comparison methods. The detection results are compared, and the samples that are inconsistent with the detection results of similar products on the market are reviewed by the the Sanger sequencing method, when the site detection results compared with Sanger sequencing method are inconsistent, Sanger's detection results are recognized. The results were determined independently according to the cutoff values or interpretation requirements provided by each method, and relevant statistics were used to evaluate clinical application performance of Genetron lung cancer panel. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Genetron Lung Cancer Panel | The main purpose of this study is: by evaluating the Genetron Lung Cancer Panel to compare the results of simultaneous detection with similar products on the market and the Sanger sequencing method, and to calculate the coincidence rate and consistency of the panel and the comparison method. | 2 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 |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | China | ||||
| The First Hospital of Jilin 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 | Dec 7, 2018 | Aug 26, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| The First Hospital of Jilin University | OTHER |
| Genetron Health (Beijing) Co., Ltd. | UNKNOWN |
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|
| Jilin City |
| China |
| The Second Affiliated Hospital Zhejiang University School of Medcine | Zhejiang | China |
| Henan Cancer Hospital | Zhengzhou | China |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |